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The need-to-know this morning:
- Amylyx Pharmaceuticals said its treatment for ALS, called Relyvrio, failed to provide any benefit for patients in a large clinical trial — a stunning outcome that now has the company considering a voluntary withdrawal of the approved medicine from the market.
“This is really hard for us, and it’s really hard for our team who care so much, but it’s so much harder for people with ALS and their families, and we have to keep that perspective,” said a somber Justin Klee, Amylyx’s co-founder and co-CEO, in an interview with STAT on Thursday evening.
- In a surprise move, the Food and Drug Administration has called for a meeting of outside advisers to discuss whether an Alzheimer’s drug from Eli Lilly should be approved, even as many outsiders expected the medicine to receive regulatory clearance this month.
The drug, donanemab, succeeded in its Phase 3 trial, resulting in a 35% slowing of Alzheimer’s disease progression versus placebo. But Lilly on Friday said that the FDA expects to call a meeting of an advisory committee to review the trial, saying that the agency had told the company “it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design” of the study.
Pharma can’t have liked Biden’s State of the Union address
In his State of the Union address, President Biden proposed expanding Medicare price negotiation — one of his most popular policies. And, as STAT’s Matt Herper writes, it’s clear that the pharmaceutical industry remains one of the biggest political targets in the country — even though they stepped up when Covid-19 hit, and have developed a new wave of remarkably effective weight loss drugs.
Historically, the industry found support among pro-business Republicans, or pro-science Democrats. But now, they are politically homeless. Some of Pharma’s reputation is earned. But Matt writes that “increasingly people who work in the drug industry are stuck between the liberal ideology of their research hotspots in Cambridge, Mass., and San Francisco and the pro-business conservatives who would protect their intellectual property and take a stand against price controls.”
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