September 27th 2023
Ryzumi is expected to be available in the first half of 2024. Pricing will be available around the time of launch.
September 26th 2023
The FDA has assigned a target action date of Jan. 31, 2024, for Dupixent to treat children 1 to 11 years of age with the inflammatory condition eosinophilic esophagitis.
September 25th 2023
The FDA is conducting an ongoing inspection of a third-party filler.
September 22nd 2023
Jardiance is currently available to treat patients with type 2 diabetes, end stage renal disease and heart failure. It has a list price of $570.48 for a month supply.
Developing novel drugs to treat cancer remains a strong focus for drug developers. Several first-in-class therapies have become available over the last few months.
FDA Approves Lilly’s BTK Inhibitor for Rare Blood Cancer
Jaypirca is the first BTK inhibitor specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor. It has a wholesale acquisition cost of $21,000 per 30 days of therapy.
FDA Approves Keytruda for Lung Cancer After Surgery
This approval marks the fifth indication for Keytruda-based regimens in non-small cell lung cancer and the 34th indication in the United States.
FDA Removes Evusheld’s EUA for COVID-19
AstraZeneca is developing a next-generation long-acting antibody for pre-exposure prophylaxis of COVID-19, which it plans to make available in the second half of 2023.
FDA to Hold Advisory Committee Meeting for ALS Drug
The Peripheral and Central Nervous System Drugs Advisory Committee meeting is scheduled for March 22, 2023, to review Biogen’s tofersen.
FDA Approves New Drug for Type 2 Diabetes
Once-daily, oral SGLT2 inhibitor Brenzavvy has been shown to reduce blood sugar and improve glycemic control.
FDA Accepts Jardiance sNDA for CKD Indication
A phase 3 trial showed that Jardiance reduced the risk of kidney disease progression or cardiovascular death in adults with chronic kidney disease by 28% compared with placebo. An FDA decision is expected in the second half of 2023.
Moderna Banks on COVID-19, RSV Vaccines
Moderna plans to submit to the FDA its investigational mRNA vaccine, RNA-1345, for respiratory syncytial virus (RSV) in the first half of 2023.
FDA Issues Complete Response for Lilly Alzheimer’s Drug
Lilly expects topline results from the confirmatory phase 3 trial in the second quarter of 2023 and plans to submit for full approval.
FDA Approves Brukinsa for Chronic Lymphocytic Leukemia
This is the fourth indication for the Bruton’s tyrosine kinase inhibitor.
FDA Approves Tukysa for HER2 Positive Colorectal Cancer
Tukysa with trastuzumab is indicated for second-line treatment of HER2-positive metastatic colorectal cancer, the first such therapy for this cancer.
FDA Accepts Application for NASH Drug
There are currently no medications approved for the treatment of NASH, which can lead to cirrhosis, eventual liver failure, cancer and death. The FDA has assigned a PDUFA target action of June 22, 2023, for the therapy, obeticholic acid.
FDA Approves Extended-Release Risperidone for Schizophrenia
Rykindo is a bi-weekly long-acting risperidone injection to treat patients with schizophrenia and bipolar 1 in adults.
FDA Approves Rybelsus for First-line Treatment of Diabetes
This update removes a previous limitation that it could not be used as the first therapy.
FDA Approves Rescue Combination Medication for Asthma
Airsupra is the first rescue medication to manage both the symptoms and the inflammation associated with asthma.
FDA Approved 49 New Therapies Last Year
New approvals include gene therapies, first-in-class drugs, treatments for rare diseases, and cancer, as well as biosimilars.
Top 15 Potential Blockbuster Drugs to Watch
Clarivate analysts have identified the treatments they forecast could deliver annual sales of more than $1 billion within five years. These include therapies for rare diseases, as well as HIV, Parkinson’s disease, Crohn’s disease, alopecia, and cancer.
FDA Accepts sNDA for Rexulti for Alzheimer’s Agitation
The agency has assigned a Prescription Drug User Fee Act target action date of May 10, 2023, and plans to hold an advisory Committee
Eisai/Biogen Submit Alzheimer’s Drug Leqembi for Full Approval
The supplemental BLA is based on data from a confirmatory phase 3 trial. The submission was made the same day Eisai/Biogen received accelerated approval.
FDA Approves Alzheimer’s Medication Lecanemab
Lecanemab, now with the brand name Leqembi, will launch with a wholesale acquisition cost of $26,500 a year.
FDA Grants Priority Review for Glofitamab for Blood Cancer
Genentech’s glofitamab is a bispecific antibody being reviewed to treat adults with large B-cell lymphoma. The FDA is expected to make a decision on approval by July 1, 2023.
FDA Accepts Second UCB Application for Generalized Myasthenia Gravis
Rozanolixizumab is a monoclonal antibody that addresses a different driver of generalized myasthenia gravis. An FDA decision is expected in the second quarter of 2023.
FDA Accepts BLA for RSV Prevention in Infants
Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.
Celltrion Submits BLA for New Formulation of Infliximab
CT-P13 SC is a subcutaneous formulation of Celltrion’s Inflectra, a biosimilar of Remicade. The BLA seeks approval to treat patients with inflammatory bowel disease.
Wegovy Approved for Teens; Supply May be Delayed
Wegovy is a once-weekly prescription medication for obesity that has faced supply issues. Its manufacturer, Novo Nordisk, is increasing production capacity in 2023.
Orasis Submits NDA for Blurry Vision Treatment
If approved, CSF-1 would be the second therapy to treat patients with presbyopia, or age-related blurry vision.
FDA Approves New Therapy for Urea Cycle Disorders
Olpruva is a new formulation of sodium phenylbutyrate to treat patients with urea cycle disorders, a genetic condition that causes ammonia to build up in the blood.
FDA Clears Twice a Year Monoclonal Antibody for MS
Ublituximab, now with brand name Briumvi, is the first anti-CD20 monoclonal antibody approved for patients with multiple sclerosis that can be administered in a one-hour infusion twice-a-year.
FDA Issues Complete Response Letter for Palovarotene
Palovarotene is a therapy for an ultra-rare disease that transforms the body’s soft tissue into bone. The FDA has requested additional information from clinical trials.
FDA Accepts Application for Nonprescription Naloxone
A decision by the FDA is expected by April 28, 2023, and, if approved, Harm Reduction Therapeutics will launch RiVive in early 2024.
Best Read Drug Approvals Stories in 2022
Among the top-read FDA approval stories include the fast-acting Auvelity to treat major depressive disorder; an extended use for Mirena IUD; the first generic of Symbicort for asthma; Camzyos, a first-in-class treatment for obstructive hypertrophic cardiomyopathy; and Imbruvica’s expanded indication for children with chronic graft versus host disease.
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