rpharma
GSK drug's new approval sets up competition with Dupixent
From my colleague Drew Joseph: The FDA yesterday approved GSK's Nucala for COPD, giving the drug a major new indication and setting up competition with Dupixent.
Nucala, which was already approved for asthma and a number of other conditions, will now be available for select patients with COPD as an add-on maintenance treatment. In clinical trials, the drug cut exacerbations among participants, while also reducing emergency department visits and hospitalizations. GSK has touted the drug's impact on hospital visits as a key victory.
Nucala sales in 2024 reached $2.4 billion, and GSK has forecast peak sales for the drug in COPD of around $675 million.
Dupixent, the juggernaut jointly marketed by Sanofi and Regeneron, was approved for certain COPD patients in September.
While Nucala's approval was expected, there was one point of intrigue around the decision. The FDA was originally meant to rule on the indication by May 7, and the delay raised questions about whether the recent cuts at the FDA had slowed down the process. It's not clear if that was the case, but it's a sign of how people will be closely following any perceived delays at the agency.
oncology
Merus drug shows preliminary survival boost in head and neck cancer
From my colleague Adam Feuerstein: Merus said Thursday that a combination of its experimental drug petosemtamab with the checkpoint inhibitor Keytruda has kept 79% of patients with newly diagnosed metastatic head and cancer alive for at least one year, according to a new analysis of a mid-stage clinical trial.
The survival data are only a snapshot. Merus, a Dutch biotech, will need to complete a larger, randomized study to prove more definitively that its drug can extend the lives of patients with head and neck cancer beyond the ability of current treatments. But for now, the preliminary survival results are encouraging and matched the expectations of investors.
Merus shares were higher in early Friday trading.
Head and neck cancer is the sixth most-common cancer worldwide. For patients with metastatic but newly diagnosed disease, standard treatment is typically Keytruda, the checkpoint inhibitor made by Merck, or a combination of Keytruda and chemotherapy. Merus is developing the combination of petosemtamab and Keytruda with the goal of helping patients with head and neck cancer live longer compared to the current standard treatment. A randomized, controlled Phase 3 study is underway, with initial results expected next year.
Read more.
infectious disease
FDA recommends new strain for Covid vaccines
The Food and Drug Administration gave Covid vaccine manufacturers instructions on what strains should be included in next fall's shots, but not without some of the drama that now seems requisite for the FDA.
The agency said that shots should be updated to the version of the virus that is circulating broadly, LP.8.1, but left an out for Novavax, which requires more lead time for manufacturing its vaccine than do Pfizer/BioNTech and Moderna, who make the mRNA-based vaccines.
What wasn't clear, even thought it was brought up twice during the panel: Exactly how these changes would mesh with a new framework for Covid vaccines that was outlined by Vinay Prasad, the new head of the FDA center that regulates vaccines, and Marty Makary, the FDA commissioner, earlier this week.
At an advisory panel held yesterday to discuss strain changes, panel members twice asked about how this new framework would interact with changing strains and whether recommending a strain change would require new clinical trials or slow down vaccine availability, but were told that the question was outside the scope of meaning, according to STAT's Helen Branswell.
Read more.
podcast
What was the mood like at a big gene therapy conference last week?
And is this biotech M&A what's putting Adam in a good mood?
I discuss this with my colleagues Adam and Allison in this week's episode of "The Readout LOUD," STAT's biotech podcast. Our colleague Jason Mast joins us for a rundown of his trip to a gene therapy conference in New Orleans. If you recall, he's previously reported that the CRISPR companies are not OK. Both CRISPR Therapeutics and Prime Medicine announced strategic shifts earlier this week. Spoiler alert: It seems that there will likely be more business moves in the months to come.
On the regulatory side, Adam breaks down the outcome of two days of FDA advisory committee meetings held to review a quarter of cancer drugs. One of the issues discussed: The applicability of study data collected in China for U.S. patients.
Listen to the Readout Loud here or wherever you get your podcasts.
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