SPOTLIGHT -
FDA Approves First Non-Steroid Cream for Psoriasis
Vtama is approved to treat adults with mild, moderate, and severe psoriasis. It is expected to be available in the first week of June 2022.
FDA Approves New Formulation of Tyvaso
Tyvaso DPI is a dry inhalation powder and new inhalation device to treat patients with pulmonary arterial hypertension, a life-threatening disease. It is expected to be available in June 2022.
FDA Accepts NDA for Nasal Migraine Treatment
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for the first quarter of 2023 for zavegepant, a nasal spray for the acute treatment of patients with migraine.
FDA Accepts BLA for Mirvetuximab Soravtansine for Ovarian Cancer
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Nov. 28, 2022.
FDA Approves Dupixent for Eosinophilic Esophagitis
Dupixent is the first medicine specifically to treat eosinophilic esophagitis, an inflammatory condition that causes the esophagus to narrow and makes it difficult to eat.
AbbVie Submits NDA for Parkinson’s Disease
ABBV-951 is a combination of foscarbidopa and foslevodopa, prodrugs of carbidopa and levodopa, that is designed to provide 24-hour, continuous subcutaneous delivery.
Study: Medicare Part D Enrollees’ Spending for Insulin Increased
If insulin copays were capped at $35, Part D enrollees would save 29% on average, according to new analysis from Kaiser Family Foundation.
FDA Issues CRL for Bimekizumab for Psoriasis
Bimekizumab, now called Bimzelx, is a monoclonal antibody being reviewed as treatment for adults with moderate-to-severe plaque psoriasis.
FDA Expands EUA for Pfizer/BioNTech COVID-19 Booster to Children 5 to 11 Years
The booster is given at least five months after completion of a primary series.
Sandoz Launches First Generic of Esbriet
Pirfenidone is used to treat patients with idiopathic pulmonary fibrosis, a progressive rare disease that make it difficult to breathe.
FDA Launches New Rare Disease Program
The goal of the new program is to help increase the development new treatments for patients with rare diseases.
Eisai Completes Submission of Lecanemab for Alzheimer’s Disease
Lecanemab is monoclonal antibody that targets beta amyloid to treat mild cognitive impairment in those with early Alzheimer’s disease.
FDA Extends Review of sNDA for Myfembree
Regulators need additional time to review information on bone mineral density. The FDA has provided a new PDUFA date of Aug. 6, 2022.
Fresenius Kabi Launches Generic of Velcade
Bortezomib is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program
Novartis Halts Production of Radioligand Therapies
The production suspension will impact both the commercial and clinical trial supplies of Lutathera and Pluvicto in the United States and Canada.
FDA Approves Enhertu for Earlier Use in Metastatic Breast Cancer
The FDA’s accelerated approval of Enhertu in later line HER2 positive metastatic breast cancer has now converted to regular approval.
FDA Schedules Advisory Committee for Nuplazid in Alzheimer’s Psychosis
The Psychopharmacologic Drugs Advisory Committee will meet on June 17, 2022; the PDUFA date is August 4, 2022.
FDA Approves Cuvrior for Rare Disease
Orphalan plans to launch Cuvrior in early 2023. It was approved to treat Wilson’s disease, which results in excess copper in the body.
FDA Issues CRL for Surufatinib for Rare Pancreatic Cancer
The FDA would like Hutchmed to conduct a multi-regional trial that includes patients who are more representative of the U.S. patient population and aligned to current U.S. medical practice.
FDA Issues CRL for Toripalimab
The regulatory agency has requested a quality process change for toripalimab, which is being developed to treat nasopharyngeal carcinoma.
FDA Approves Qelbree for ADHD in Adults
Qelbree is the first new nonstimulant to be approved in 20 years.
FDA Issues CRL for Migraine Therapy
The complete response letter identified the need for additional chemistry, manufacturing, and controls data related the drug product and manufacturing process.
FDA Advisory Committee to Review Novavax COVID-19 Vaccine
The FDA’s Vaccines and Related Biological Products Advisory Committee has scheduled a meeting on June 7, 2022.
FDA Approves Vivjoa for Chronic Yeast Infections
Vivjoa is an oral therapy and the first for chronic yeast infections. It is expected to be available in the second quarter of 2022.
The FDA Approves Ultomiris for Myasthenia Gravis
Ultomiris is the first approval for a long-acting C5 complement inhibitor for the treatment of generalized myasthenia gravis, a rare, chronic, autoimmune neuromuscular disease.
FDA Accepts BLA for Liver Cancer Therapy Tremelimumab
The FDA has set a Prescription Drug User Fee Act date for tremelimumab during the fourth quarter of 2022.
Pfizer Recalls Five Lots of Accupril
Higher than normal levels of nitrosamine have been detected. Long-term exposure to high amounts of nitrosamine can lead to cancer.
FDA Accepts Resubmitted BLA for Cosmetic Therapy
The new PDUFA date for is Sept. 8, 2022, for daxibotulinumtoxinA, Revance’s therapy to treat frown lines.
Breckenridge Gets FDA Approval of One Generic and Launches Two Others
The FDA has approved miglustat for Gaucher disease. Breckenridge launches pencillamine for Wilson’s disease and lacosamide for seizure disorder.
IQVIA: Medication Use Reached Record Levels Last Year
An estimated additional 81 million prescriptions were abandoned at the pharmacy because of high out-of-pocket costs for patients.