July 3, 2024

The need-to-know this morning

GSK and CureVac restructured an ongoing partnership that gives the British pharma giant control over the development of experimental mRNA-based Covid and flu vaccines.

alzheimer's

Lilly sees Alzheimer's approval as a 'first step'

After several regulatory hurdles, Eli Lilly's early Alzheimer's therapy donanemab got approved by the FDA yesterday. Sold under the brand name Kisunla, it will now compete against Eisai and Biogen's Leqembi.

While the approval is a win for Lilly, the drug will likely face early challenges with uptake. It's administered as an infusion, and there are logistical issues around convenience and capacity of infusions. There's also growing skepticism among doctors about the effectiveness of anti-amyloid therapies, especially when weighing the risk of brain swelling for patients on these treatments.

In an interview, Lilly executives admitted that anti-amyloid medicines are only a first step in combating the disease. "We've said this is an incredibly important first step, but it is not a cure for Alzheimer's disease," said Mark Mintun, group vice president of neuroscience research and development at Lilly. While reducing amyloid is "clinically important," another approach will be to develop medicines that target a different brain protein called tau, he said.

inflammation

EU approves Dupixent for chronic lung disease

The European Medicines Agency approved Regeneron and Sanofi's Dupixent as an add-on maintenance treatment in adults with uncontrolled COPD, the first region in the world to grant clearance for this indication.

Dupixent is already a blockbuster drug, bringing in billions in revenue in several diseases such as asthma, atopic dermatitis, and eosinophilic esophagitis. But going into COPD, a chronic inflammatory lung disease, is a major expansion. The companies estimate that 220,000 adults in the EU with the condition could be eligible for treatment.

In the U.S., the FDA extended its review of this indication by three months. A decision is now expected by Sept. 27.

Going into regulatory submissions, the companies had positive data from two Phase 3 trials showing that Dupixent reduced COPD flare-ups and improved lung function.

policy

BIOSECURE Act has spooked U.S. biotechs

A new report finds that the looming BIOSECURE Act has made U.S. drug companies wary of Chinese partnerships.

The bill, which is still just a proposal but has traction in Congress, would prevent American biotechs from contracting with or receiving grants from the government if they work with a Chinese "biotechnology company of concern."

Since the introduction of the bill this year, U.S. biotechs' confidence in working with Chinese companies has dropped by up to 50%, according to the report, by L.E.K. Consulting. A quarter of U.S. biotechs are considering shifting away from their current Chinese suppliers, though only 2% have done so.

politics

Biden joins in on bashing Ozempic prices

In an op-ed yesterday, President Biden teamed up with Sen. Bernie Sanders to slam Novo Nordisk and Eli Lilly over prices they've set for blockbuster GLP-1-based treatments Ozempic and Mounjaro.

This comes as Sanders, chair of the Senate health committee, probes Novo's prices and has called the CEO to testify before the committee.

Novo and Lilly are "charging unconscionably high prices" and the drugs "have the potential to bankrupt the American health care system," Biden and Sanders wrote. "If Novo Nordisk and other pharmaceutical companies refuse to substantially lower prescription drug prices in our country and end their greed, we will do everything within our power to end it for them."

How much will such statements result in actual actions? Mizuho analyst Jared Holz wrote that he doesn't think this will lead to any near-term price reduction and that the pharma companies might actually go on the offensive in proving the merits of their drugs. Overall, it "seems like a last-ditch effort to appease certain voters," he said.

biotech

A bad week for Cassava Sciences

My colleague Adam Feuerstein is back with a brief look at his Biotech Scorecard newsletter this week:

Thanks, Elaine! This week's newsletter takes a deeper look at the escalating legal troubles enveloping Cassava Sciences and its controversial Alzheimer's drug candidate simufilam. I love a good biotech scandal. We haven't had a story this entertaining since Sam Waksal tipped off Martha Stewart about Imclone.

Also, a novel twist on clinical trial data spin from Cartesian Therapeutics.

Adam's Biotech Scorecard is delivered to STAT subscribers every Thursday morning (every week but this holiday week). You can sign up for your own email copy here, or read it on the web here.

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