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Morning Briefing

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Friday, Jun 18 2021

Full Issue

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.

Two-thirds of Americans who are familiar with the details of the newly approved Alzheimer鈥檚 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)

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鈥檚 drug in almost two decades. 鈥淥bviously, I am very happy to have this,鈥 said Archambault, 70, who is in an early stage of the disease. 鈥淚t鈥檚 amazing.鈥 The celebratory air at the news conference masked a growing furor over the Food and Drug Administration鈥檚 highly contentious approval of the drug, called Aduhelm, last week. (McGinley, 6/17)

In other pharmaceutical news 鈥

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.聽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.聽(Hein, 6/17)

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鈥檚 a need for yet newer drugs that can overcome any resistance the cancer evolves. (Molteni, 6/17)

The chief executive of Athira Pharma, a biotech developing treatments for Alzheimer鈥檚 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)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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