FDA Blocks 10 E-Cigarette Companies’ Sales
The FDA blocked them from marketing or distributing 6,500 flavored e-liquid and e-cigarette products. The FDA also approved a once-a-day menopause drug. In a split vote, an advisory panel to the agency recommended the FDA approve the first gene therapy for Duchenne muscular dystrophy.
The Washington Post:
FDA Blocks Marketing On 6,500 Flavored E-Cigarette Products
The Food and Drug Administration on Friday blocked 10 companies from marketing or distributing 6,500 flavored e-liquid and e-cigarette products, part of its campaign against tobacco products being marketed to youths. The agency said the product applications covered a variety of flavored e-cigarettes, including some with flavors such as Citrus and Strawberry Cheesecake, as well as Cool Mint and Menthol. The FDA said the companies in question did not provide sufficient evidence that marketing the products would be appropriate for public health. (Werner, 5/12)
On menopause —
USA Today:
Menopause Drug Veozah Approved By FDA To Treat Hot Flashes
The Food and Drug Administration has approved a once-a-day pill for dealing with uncomfortable hot flashes brought on by menopause. The new drug, Veozah (fezolinetant), differs from the traditional treatment of boosting the hormones estrogen and progestin to reduce menopause symptoms, which include sweating, flushing and chills. Developed by Astellas Pharma, Veozah blocks a chemical in the brain called neurokinin B (NKB), which regulates body temperature. (Snider, 5/13)
On Duchenne muscular dystrophy —
NPR:
FDA Duchenne Muscular Dystrophy Gene Therapy
In a split vote, advisers to the Food and Drug Administration recommended that the agency approve the first gene therapy for Duchenne muscular dystrophy, the most common form of the genetic illness. The vote, 8 to 6, came after a day of testimony from speakers for Sarepta Therapeutics, the maker of the gene therapy called SRP-9001, FDA scientists and families whose children have Duchenne muscular dystrophy. The question before the panel was whether the benefits for the treatment outweigh the risks. (Hensley and Stein, 5/12)
More about the FDA —
Reuters:
Eisai, Biogen Alzheimer's Drug Leqembi Would Cost US Medicare Up To $5 Bln A Year, Study Finds
Wide coverage of Alzheimer's drug Leqembi would raise future costs for the U.S. Medicare health plan by $2 billion to $5 billion a year, according to a study led by researchers at the University of California, Los Angeles (UCLA). Leqembi, sold by partners Eisai Co Ltd and Biogen Inc at an annual list price of $26,500, was approved this year under the U.S. Food and Drug Administration's accelerated pathway. Trial results later showed it slowed the rate of cognitive decline by 27% compared with a placebo in patients with early disease. (Beasley, 5/12)
Bloomberg:
FDA Fast Tracked Drugs Make Companies Billions On Unproven Claims
When Exondys 51 was approved to treat Duchenne muscular dystrophy, a deadly disease that puts kids in wheelchairs by the time they are teenagers, there was no proof the drug actually slowed the disease. That was seven years ago. The company still hasn’t provided conclusive data to this day. (Langreth, Rutherford, John Milton and Campbell, 5/14)
In other pharmaceutical news —
Stat:
Compounding Pharmacies Can Help Address Drug Shortages
In the early days of the Covid pandemic, gravely ill patients began to fill America’s hospitals. Hospitals ran short of essential treatment medications and were unable to source those drugs from manufacturers or from the outsourcing facilities that had been authorized by Congress in 2013 to “fill the gap” in such situations. At the urging of the Alliance for Pharmacy Compounding, the trade association I lead, the Food and Drug Administration in April 2020 issued temporary guidance allowing traditional compounding pharmacies, within tight regulatory guardrails, to prepare 13 Covid drugs from pure ingredients to meet hospitals’ urgent need. (Brunner, 5/15)
