Trump administration quietly releases second round of Medicare-negotiated prices

The Trump administration last night unveiled the prices for 15 drugs that were in the second round of Medicare negotiations, saying it saved $8.5 billion, or 36%, compared to what it would've paid last year had the negotiated prices been in effect.

Though officials in the announcement played up their negotiating prowess as superior to that of their counterparts in the Biden administration, the timing and process of announcing the negotiated prices seemed designed to avoid attention. Unlike Trump's recent deals with individual drugmakers, there was no White House press event. The administration released the prices around 6 p.m. EST on Tuesday, and didn't alert the press in advance, as they've done for other drug announcements.

The highest profile drug in this round was Novo Nordisk's semaglutide, marketed as Ozempic and Wegovy. The administration already announced price cuts for this drug, as part of a voluntary agreement with Novo. Notably, the $245 a month price arrived at through the voluntary deal is lower than the prices announced yesterday as part of the Medicare negotiation program (for example, include $276.78 a month for commonly used doses of Ozempic and Rybelsus, and $385.63 a month for the highest dose of Wegovy.)

One expert called this "disappointing."

biotech

FDA approves Otsuka's kidney drug, paving the way for novel mechanism

The FDA yesterday approved a novel drug from Otsuka to treat a chronic, autoimmune kidney disease.

The drug, called Voyxact, is part of an emerging class of drugs for IgA nephropathy, or IgAN, a disease caused by the build-up of immune antibodies in the kidneys. The condition, which leads to progressive loss of kidney function, can be addressed with existing drugs, but some patients still continue to decline and need new therapies with different modes of action.

Voyxact works by blocking a protein called A proliferation-inducing ligand, or APRIL. Vera Therapeutics and Vertex Pharmaceuticals are developing similar treatments.

gene therapy

Sarepta cleared to test new safety regimen for Duchenne drug

From my colleague Jason Mast: Sarepta Therapeutics said yesterday that the FDA has cleared it to begin testing whether adding a new immune-suppressing drug would allow it to safely dose older Duchenne muscular dystrophy patients with its gene therapy Elevidys.

Elevidys was removed from the market for older patients several months ago, after two teenage boys died of liver failure after receiving the treatment.

The new study will determine whether the drug sirolimus can mitigate liver risks in 25 patients. The trial is set to begin later this year and deliver data in the second half of next year. But it remains unclear what data the FDA would need in order to allow the drug back onto the market for these older patients.

The treatment had been greeted by some as their best hope against a relentless, universally fatal disease. But it showed mixed efficacy data in younger patients and Sarepta has produced almost no efficacy data on the drug in older patients. Other gene therapies are on the horizon.

regulation

Prasad outlines his research philosophy to FDA staff

Over the weekend, Vinay Prasad, the chief gene therapy and vaccine regulator at the FDA, sent a long memo to staff members explaining how he wants them to prioritize and conduct research.

"We have a special duty to the American people: to do research that furthers the regulatory mission. And we have a duty to science, to only do work that is honest and defensible," he wrote in the memo, a copy of which was obtained by my colleague Adam Feuerstein. He added that "we owe it to taxpayers to ensure [the FDA's research] is a wise use of money."

Throughout the memo, he stressed that he wants to see "accurate," "truthful," and "honest" research, criticizing studies that lack negative controls and are affected by confounding.

He also said that staff needs to focus on research that furthers the FDA's regulatory mission, rather than spend resources on studies that the pharma industry could do on its own and benefit from, such as research to broaden marketing authorization.

Read the full memo here.

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