FDA expanded the approved indication for baloxavir marboxil (Xofluza, Genentech) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu.

In addition, the drug, previously available only in tablet form, is now available as granules for mixing in water, FDA said in a 

Gottlieb optimistic about COVID-19 end after positive Moderna vaccine results

“This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Americans will have to be more vigilant than ever as these viruses spread concurrently.”

 in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

Pfizer: COVID-19 vaccine likely ready late November

Xofluza’s safety and efficacy for post-flu exposure prevention is supported by one randomized, double-blind, controlled trial.

The trial included around 600 subjects who were exposed to a person with influenza in their household. The trial’s primary endpoint was the proportion of subjects who were infected with influenza virus and presented with fever and at least one respiratory symptom from day 1 to day 10. Of those who received Xofluza, 1% of subjects met these criteria compared with 13% of those in the placebo group.

FDA approves game-changing influenza drug

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FDA official says the approval is important because of the combination of the flu season and the COVID-19 pandemic.

Xofluza, flu drug, snags new indication

FDA has cleared the monoclonal antibody treatment for COVID-19 that President Donald Trump was treated with in October. The agency also gave the go-ahead late last week to the first home self-test for the pandemic disease.

The agency issued an emergency use authorization (EUA) for casirivimab and imdevimab (Regeneron) to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kg.) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

FDA grants emergency use for COVID-19 treatment

Earlier this month, FDA issued an EUA for the another monoclonal antibody therapy, bamlanivimab (Eli Lilly and Company), to treat mild-to-moderate COVID-19 in adult and pediatric patients.

“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our healthcare system,” said FDA Commissioner Stephen M. Hahn, M.D., in a 

. “As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments.

In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together via IV infusion, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared with placebo.

However, FDA said that the combination therapy is not authorized for patients who are hospitalized with COVID-19 who require oxygen therapy because of the disease; in fact, the agency said the treatment might worsen the condition of such patients.

U.S. government, AstraZeneca team up on COVID-19 preventative med

“A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation,” FDA said.

FDA also granted an EUA for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit (Lucira Health) is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, the agency said in a 

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” Hahn said.

The Lucira COVID-19 All-In-One Test Kit test, available by prescription only, is authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their healthcare provider.

It is also authorized for use in point-of-care (POC) settings such as doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages. However, samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old.

Regeneron's investigational treatment was administered to President Donald Trump in October when he was treated for COVID-19.

 FDA clears Regeneron's COVID-19 monoclonal antibody treatment and a home test

The COVID-19 pandemic could “effectively” be ended in 2021, said Scott Gottlieb, MD, former FDA commissioner, after Moderna announced very positive results from its vaccine trial.

 that its Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has an efficacy of 94.5%. Its COVE study enrolled more than 30,000 participants in the U.S.

Pfizer and BioNTech’s first interim analysis also found that their vaccine candidate, BNT162b2, 

 against COVID-19 in participants without prior evidence of SARS-CoV-2 infection.

Pfizer COVID-19 vaccine results positive, but questions remain

Pfizer expects the FDA to grant emergency approval for the vaccine later this month.

"If these full data sets hold, when the full data comes out, we may have two highly effective vaccines against Covid," Gottlieb, a board member of Pfizer, said on CNBC’s “Squawk Box."​ 

"Once we get these vaccines in sufficient qualities heading in 2021, the combination of the fact that a lot of the population will have already had COVID, combined with the fact that we'll be vaccinating the public with a highly effective vaccine, we could effectively end this pandemic in 2021 with our technology," Gottlieb said.

Michael Breen, Ph.D., director of infectious diseases and ophthalmology at GlobalData, praised the efficacy date for both Moderna and Pfizer’s vaccine candidates.

“While the efficacy of Moderna’s offering is slightly higher than that reported for Pfizer/BioNTech’s candidate, the more pressing point is the fact that these vaccines achieved this outcome at all. One candidate seeing significantly more impressive results than the FDA’s usual bar was great news, but two is unprecedented,” Breen said in a press release.

One key difference between the vaccines is that Moderna’s vaccine does not require deep-freeze storage, while Pfizer’s does, Breen said. “This creates significant logistical difficulties that could easily give the advantage for COVID-19 vaccines to Moderna.”

“More data are needed for both vaccines that might highlight differences between them and inform how each should be used. It is entirely possible that both vaccines have similar efficacies across all groups, in which case they should both be rolled out as rapidly as possible,” Breen added.

FDA approved a new indication for Merck’s blockbuster cancer drug, pembrolizumab (Keytruda), in combination with chemotherapy, to treat locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC).

Sales of Keytruda, approved to treat several different types of cancer including non-small-cell lung cancer, soared 21%, to $3.7 billion, in the third quarter of 2020.

Merck’s Keytruda snags another cancer indication

“Today’s approval is a significant milestone, as it represents the first approval for Keytruda in the breast cancer setting,” said Roy Baynes, M.D., senior vice president and head of global clinical development, chief medical officer of Merck Research Laboratories, in a 

In the phase 3 trial supporting the approval, Keytruda in combination with paclitaxel, nab-paclitaxel or gemcitabine and carboplatin, significantly improved progression-free survival for patients with advanced triple-negative breast cancer whose tumors express PD-L1 with combined positive score (CPS) greater than or equal to 10 compared with the same chemotherapy regimens alone, Baynes added.

Keytruda, in combination with the chemotherapy agents, reduced the risk of disease progression or death by 35% for patients whose tumors express PD-L1 versus the same chemotherapy regimens alone

FDA okays novel breast, colorectal cancer treatments

The multicenter, double-blind, randomized, placebo-controlled trial included 847 patients with locally recurrent unresectable or metastatic TNBC, regardless of tumor PD-L1 expression, who had not been previously treated with chemotherapy in the metastatic setting.

FDA granted accelerated approval for the indication based on progression-free survival (PFS), so continued approval for that indication may be contingent upon verification and description of clinical benefit in the confirmatory trials, Merck said.

“Approximately 15 to 20% of patients with breast cancer are diagnosed with triple-negative breast cancer, which is a difficult-to-treat and aggressive cancer,” said Dr. Hope Rugo, director of Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center. “The approval of Keytruda in combination with chemotherapy gives physicians an important new option for appropriate patients.”

Merck earned a new indication for pembrolizumab (Keytruda), in combination with chemotherapy, to treat locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC).


Blockbuster Keytruda earns new breast cancer indication

FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab (Eli Lilly and Company) to treat mild-to-moderate COVID-19 in adult and pediatric patients.

Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 88 pounds and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

“This includes those who are 65 years of age or older, or who have certain chronic medical conditions,” FDA said in a 

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"This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients — adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic," said David A. Ricks, Lilly's chairman and CEO, in a 

Lilly will begin shipping bamlanivimab immediately to AmerisourceBergen, which will distribute it as directed by the U.S. government's allocation program.

The EUA is based on data from BLAZE-1, a randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization, FDA said.

“While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” FDA said.

"The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus," said Daniel Skovronsky, MD, PhD, chief scientific officer for Lilly and president of Lilly Research Laboratories.

The frequency and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity. Infusion reactions and other allergic hypersensitivity events have been reported, and the EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.

Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. “Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation,” FDA said.

The EUA allows for bamlanivimab to be distributed and administered as a single dose intravenously by health care providers.

For information regarding access to bamlanivimab, patients should speak with their health care providers, and health care providers should contact their state health department directly, Lilly said.

 FDA expands emergency use authorization for remdesevir to include all hospitalized COVID-19 patients

The investigational monoclonal antibody therapy bamlanivimab treats mild-to-moderate COVID-19 in adult and pediatric patients.

While Pfizer and BioNTech’s first interim analysis demonstrates the efficacy of their SARS-CoV-2 vaccine candidate, some questions remain.

The vaccine candidate, BNT162b2, demonstrated a 90% efficacy rate against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted by an external, independent Data Monitoring Committee (DMC), the pharmaceutical manufacturers said in a 


“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” said Albert Bourla, MD, Pfizer Chairman and CEO. “With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

In addition, the DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned, Pfizer and BioNTech said.

While Pfizer and BioNTech’s vaccine candidate has “greatly exceeded the efficacy bar of 50% [for seasonal influenza vaccines] set by the FDA, several questions remain, said Philipp Rosenbaum, PhD, Senior Infectious Diseases Analyst at GlobalData, in a press release. 

“The efficacy percentage could still decrease in the final analysis, and important questions about how well the vaccine can prevent severe cases of COVID-19, its effect on carriage and transmission of the virus, and the long-term protection will take many more months to be answered,” Rosenbaum said.

In addition, with 50 million doses available by the end of the year and 1.3 billion in 2021, “concerns about the supply and distribution of COVID-19 vaccines, especially for mRNA vaccine such as Pfizer’s that require deep-freeze storage and have a rather short shelf-life at refrigerator temperatures, will only add barriers,” he added.

“Saying that, the speed of which this efficacy announcement has been made — a mere seven months after the companies started their first Phase I study — has been really quite impressive,” Rosenbaum said.

Dozens of other companies are also developing COVID-19 vaccines, and Phase 3 data from Moderna, AstraZeneca, and Johnson & Johnson, are expected soon, Rosenbaum added.

“Many manufacturing and supply deals have been made, and most of the companies already started manufacturing ahead of Phase III results. Having multiple vaccines available with even slightly lower efficacy would be immeasurably beneficial for controlling the outbreak, giving runway to ramping up manufacturing and bolstering of distribution channels for more effective vaccines,” Rosenbaum said.

U.S. government secures remdesevir supply for COVID-19 patients

Several months after the first metformin recall, Nostrum Laboratories this week said it is voluntarily recalling two lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level.

"The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day,” the company said in a 

The metformin — indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus — is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01.

, when FDA found elevated NDMA levels in products from five different manufacturers.

At the time, Apotex Corp recalled all lots of its metformin hydrochloride extended-release tablets, USP 500 mg, within expiry to the retail level.

Similarly, Amneal recalled all lots of metformin hydrochloride extended-release tablets, USP, 500 mg and 750 mg, within expiry to the retail levels. The affected products were distributed nationwide in the US directly to wholesalers, distributors, retailers, and repackagers.

Sun Pharma recalls 1 lot of metformin due to NDMA levels

 one lot of its metformin hydrochloride for extended-release (ER) oral suspension (Riomet ER), 500 mg per 5 mL to the consumer level due to a higher than allowed level of NDMA.

NDMA is a probable human carcinogen and a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables, Nostrum said.

However, Nostrum has not received reports of adverse events related to the recall.

, including details about metformin products that have been recalled.

Two metformin products recalled, more on the way

Recalls of metformin products due to higher levels of the probable carcinogenic ingredient N-Nitrosodimethylamine (NDMA) than allowed continue.

Metformin recalls continue

President Donald Trump joked about potentially firing National Institute of Allergy and Infectious Diseases Director Anthony S. Fauci after the election, as Fauci criticized the United States’ handling of coronavirus pandemic.

Fauci said the U.S. needs to make an “abrupt change” in public health practices and behaviors and is “in for a whole lot of hurt” heading into the winter season, 

The U.S. set a new daily coronavirus case record October 30, peaking at 98,859. The country could surpass 100,000 new cases a day and the death rate will also likely increase, according to Fauci.

Deaths from COVID-19 have surpassed 230,000 since the start of the pandemic.

However, leading up to the election, Trump has downplayed the pandemic and has praised his Administration’s response to it. “You live with [the coronavirus], and you know what to do — we understand it now, you’ve got to understand it. But we’re making that beautiful turn, and the vaccines are coming,” the president said at a rally recently, 

At a rally in Florida last week, when the crowd chanted, “Fire Fauci, Fire Fauci,” Trump responded, “Don’t tell anybody, but let me wait until a little bit after the election. I appreciate the advice,” 

Trump, Fauci disagree on the effectiveness of hydroxychloroquine

Meanwhile, Fauci warned Americans about the pandemic worsening.

“We’re in for a whole lot of hurt. All the stars are aligned in the wrong place as you go into the fall and winter season, with people congregating at home indoors,” he said in an interview 

 reported. “You could not possibly be positioned more poorly.”

Fauci also said the White House coronavirus task force meets less frequently and has far less influence as the president and his top advisers have focused on reopening the country. “Right now, the public health aspect of the task force has diminished greatly,” he said.

Fauci added he has not spoken to Trump since early October. “The last time I spoke to the president was not about any policy; it was when he was recovering in Walter Reed, he called me up,” he said.

Trump jokes about potentially firing NIAID Director Anthony S. Fauci.

Trump, Fauci spar over U.S. coronavirus response

TG Therapeutics was granted FDA Fast Track Designation for its investigational treatment for chronic lymphocytic leukemia (CLL).

The treatment is a combination of ublituximab, its investigational glycoengineered anti-CD20 monoclonal antibody, and umbralisib, the company’s investigational once-daily, oral, dual inhibitor of PI3K-delta and CK1-epsilon.

FDA grants full approval for combination leukemia treatment

The application for Fast Track was based on data from the UNITY-CLL Phase 3 study that TG announced earlier this year had met its primary endpoint of progression free survival.

"We are extremely pleased to have received Fast Track designation for the ublituximab plus umbralisib regimen, or the U2 combination, to treat adult patients with CLL,” said Michael S. Weiss, executive chairman and CEO of TG Therapeutics, in a press release.

“This designation holds several important advantages to potentially expedite the development and regulatory review of U2 and underscores the significant unmet medical need that still exists for patients with CLL.” Weiss said.

 FDA approves new indication for leukemia drug

UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the U2 combination to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL).

The trial enrolled approximately 60% treatment-naïve CLL patients and 40% relapsed or refractory CLL patients.

 (Venclexta, Genentech) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC)to treat acute myeloid leukemia (AML).

Venclexta, specifically designated to treat newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy, was previously granted provisional approval under FDA’s accelerated approval program in late 2018.

FDA fast tracks investigational leukemia treatment 

After the FDA granted the first Investigational New Drug Application (IND) for a gummy medication, will more medicines be delivered via gummies in the future?

Seattle Gummy Company received the IND for its allergy gummy medication, IND 140312. The company’s gummy drug program delivers Active Pharmaceutical Ingredients (APIs) into a novel gummy matrix, “thus solving drug solubility, stability, and taste issues,” Seattle Gummy Company said in a 

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With its initial focus on the most common OTC drugs, the company currently has several gummy drugs under review with the FDA.

Seattle Gummy Company’s gummy medication development program, which began three years ago, was inspired by the popularity of gummy vitamins, which are increasingly taken by both children and adults.

In fact, the global gummy vitamins market is valued at an estimated $5.9 billion in 2020 and is projected to reach $10.6 billion by 2025, MarketsandMarkets said in a 

“The increasing prevalence of vitamin deficiencies and undernourishment, along with growing demand and awareness for on-the-go supplements, supporting better health among consumers, is driving the majority growth of the global gummy vitamins market,” MarketsandMarkets said. “Apart from that, the hike in need for immunity boosting or supporting products, as a preventive healthcare measure, is further rocketing the growth of the gummy vitamins market.

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"I was so frustrated forcing these yucky and sticky syrup medicines into my son when he was sick. I kept telling myself that there has to be a better way of giving kids medications," said Dr. Connie Wan, founder and CEO of Seattle Gummy Company. “Then, when I saw a bottle of gummy vitamins in Costco, a light bulb went off.”

The manufacturer has a large pipeline of gummy drugs in development, from allergy and pain relief medications to fever reducers and cough suppressants, according to Wan.

“We are focusing on the pediatric and geriatric market. Did you know one-third of the senior population can't swallow tablets, and that medication non-adherence is the biggest problem in medicine? We are here to solve these problems.”

SGC formulates each medication into both regular and sugar-free versions and manufactures several dosage strengths of each medication.

Medical company secures Investigational New Drug Application from FDA for its gummy medication.