Official In Charge Of Aduhelm Approval To Depart FDA
Stat reports that Billy Dunn, who presided over the controversial approval of the Alzheimer's drug Aduhelm, will retire to pursue other opportunities. Meanwhile, CBS News says the FDA has recently approved the first drug that can slow the vision-loss illness geographic atrophy.
Stat:
FDA's Billy Dunn, Key Figure In Aduhelm Approval, To Leave Agency
Billy Dunn, who presided over the polarizing approval of the Alzheimer’s disease treatment Aduhelm, is leaving the Food and Drug Administration after more than 15 years at the agency, STAT has learned. Dunn, 53, is retiring from the agency to “explore other opportunities,” according to an internal FDA email sent Monday. (Feuerstein and Garde, 2/27)
In other news from the FDA —
CBS News:
New FDA-Approved Drug Can Slow Vision Loss For Those With Age-Related Eye Disease Geographic Atrophy, A Form Of Macular Degeneration
The Food and Drug Administration recently approved the first drug to treat geographic atrophy, a form of macular degeneration, which affects a person's central vision. Syfovre will be available as an injection and can slow the progression of the disease, although it will not reverse it. The drug is expected to be on the market in early March. An injection will be needed every one to two months and a vial will cost $2,190, according to Apellis Pharmaceuticals. (Lapook, Ann Winick and Novak, 2/27)
Stat:
For Cytokinetics, FDA Rejection Of Heart Drug Would Help, Not Hinder
Cytokinetics was founded 26 years ago but has not yet developed a drug successfully to approval. That makes Tuesday’s Food and Drug Administration decision on its treatment for heart failure a big deal — except nearly everyone, even investors who own Cytokinetics — hopes the agency rules against it. (Feuerstein, 2/27)
Stat:
FDA Is Petitioned To Boost Enforcement Of Trial Sponsors
An organization that promotes and studies clinical trial disclosure has petitioned the Food and Drug Administration to take several steps to boost its enforcement of wayward trial sponsors and investigators that fail to register studies and report results. (Silverman, 2/27)
And more pharmaceutical developments —
The Wall Street Journal:
Altria In Talks To Buy Vaping Startup NJOY For At Least $2.75 Billion, Divest Its Stake In Juul
Marlboro maker Altria Group Inc. is in advanced talks to buy e-cigarette startup NJOY Holdings Inc. for at least $2.75 billion and plans to divest its stake in Juul Labs Inc., according to people familiar with the matter. The deal for NJOY, one of the few e-cigarette makers whose products have clearance from federal regulators, could be announced as soon as this week, the people said, though the talks could still fall apart. (Maloney, Chung and Thomas, 2/27)
The New York Times:
A Drug Company Exploited A Safety Requirement To Make Money
The pharmaceutical industry is rife with tales of companies dreaming up ways to prolong their monopolies on lucrative drugs. They tinker with chemicals. They tweak dosing. They swap out capsules for tablets. By piling up patents, drug companies delay the day when competitors can introduce similar, cheaper products. Jazz Pharmaceuticals has figured out a way to push the boundaries even further — a feat that demonstrates the lengths to which drug makers go to eke out extra profits and that two federal courts have now ruled was improper. (Robbins, 2/28)
The Wall Street Journal:
What Happens When You Stop Taking Ozempic?
People who stopped taking semaglutide gained back, on average, two-thirds of the weight they lost within a year, according to a study published in August 2022 in the journal Diabetes, Obesity, and Metabolism. Novo Nordisk funded the trial. “Some people don’t have an awareness that this might have to be a medication that will be lifelong,” said Alexandra Sowa, an obesity medicine physician in New York. Dr. Sowa said more than half of her new patients are asking about semaglutide. (Janin, 2/27)
