Many Have Mixed Feelings About Using Alzheimer’s Drug, Poll Finds
People say they are concerned about the FDA's regulatory process but are excited about the drug itself. In other pharmaceutical news, the FDA has granted its "Breakthrough Therapy" designation for Novartis' experimental therapy targeting advanced castration-resistant prostate cancer.
Stat:
Poll: Many Americans Concerned About FDA Process For Alzheimer's Drug
Two-thirds of Americans who are familiar with the details of the newly approved Alzheimer’s treatment believe the medication will be effective, but have concerns about the regulatory process used to endorse the drug and are divided over whether the drug, which will cost $56,000, is fairly priced, according to a new survey from STAT and The Harris Poll. The responses underscore that the Food and Drug Administration approval this month of the drug, called Aduhelm, has proven divisive among a wide array of experts and the poll shows the same is true for the U.S. public. Among those who had only heard about the approval, slightly more than half agree the drug will be effective, but were concerned about the FDA process. (Silverman, 6/18)
The Washington Post:
Furor Rages Over FDA Approval Of Controversial Alzheimer’s Drug
Marc Archambault smiled broadly Wednesday as he walked to the microphones at Butler Hospital in Providence, R.I. The silver-haired real estate agent was about to become the first person outside of a clinical trial to be treated with a new Alzheimer’s drug in almost two decades. “Obviously, I am very happy to have this,” said Archambault, 70, who is in an early stage of the disease. “It’s amazing.” The celebratory air at the news conference masked a growing furor over the Food and Drug Administration’s highly contentious approval of the drug, called Aduhelm, last week. (McGinley, 6/17)
In other pharmaceutical news —
Fox News:
Novartis Experimental Prostate Cancer Drug Gets FDA Breakthrough Designation
Novartis announced on Wednesday that the FDA granted Breakthrough Therapy designation to an experimental therapy that targets advanced castration-resistant prostate cancer. The agency said the decision was based on positive data from a Phase 3 clinical trial evaluating LuPSMA-617. Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the potential for substantial improvement over available therapy. (Hein, 6/17)
Stat:
Scientists Unshelve A Decades-Old Antibiotic To Fight Ovarian Cancer
Ovarian cancer, which kills about 15,000 Americans every year, has historically been one of the thornier cancers to treat. Only in the last few years has a new class of potent drugs, called PARP inhibitors, started to change that. But even with these promising new treatments, too often, tenacious tumors come roaring back. So there’s a need for yet newer drugs that can overcome any resistance the cancer evolves. (Molteni, 6/17)
Stat:
Athira Pharma CEO Placed On Leave Amid Claims Of Altered Images
The chief executive of Athira Pharma, a biotech developing treatments for Alzheimer’s and other neurodegenerative diseases, has been placed on temporary leave as her former university investigates claims she published several papers containing altered images while she was a graduate student. The Seattle-based company did not disclose the reasons for the investigation of Leen Kawas, but STAT has learned that it involves allegations of altered images in four separate papers on which Kawas is the lead author. (Goldhill, 6/17)
