Can a GLP-1 drug slow Alzheimer's disease? Nope

Novo Nordisk said this morning that a pair of large, placebo-controlled clinical trials testing an oral version of its GLP-1 drug semaglutide failed to slow the cognitive decline of participants with Alzheimer's disease.

The negative study results were disappointing, although not particularly surprising, even for a class of drugs that has been found to have effects on the body well beyond metabolism. Semaglutide is the active ingredient in Novo's blockbuster obesity and diabetes drugs Ozempic and Wegovy.

"Based on the significant unmet need in Alzheimer's disease as well as a number of indicative data points, we felt we had a responsibility to explore semaglutide's potential, despite a low likelihood of success," Martin Lange, Novo's chief scientific officer, said in a statement. "We are proud to have conducted two well-controlled Phase 3 trials in Alzheimer's disease that meet the highest standards of research and rigorous methodology."

drug pricing

CMS closes in on deadline to disclose IRA prices

There are just days to go until CMS faces its Nov. 30 deadline to publicly disclose the maximum fair prices it negotiated for the 15 Part D drugs selected for 2027 — a list that includes Xtandi, Ibrance, and other blockbuster therapies.

President Trump has boasted that his deals would be better than President Biden's, and experts note that his administration might indeed secure greater savings for a variety of reasons.

Manufacturers submitted data March 1, and CMS must finalize and publish any agreed-upon prices before the month ends. These numbers will shape Medicare spending, patient out-of-pocket costs, and serve as a major test of the Inflation Reduction Act's drug-pricing power.

WALL STREET

Lilly hits trillion-dollar valuation as GLP-1 era peaks

Eli Lilly just became the first health-care company to cross the $1 trillion valuation mark, powered by runaway demand for its GLP-1 drugs Zepbound and Mounjaro.

Under CEO Dave Ricks, Lilly has added more than $900 billion in market value and cemented itself as the dominant player in obesity and diabetes medicines as Novo Nordisk stumble.

A new pricing deal with the Trump administration recently boosted the company's stock further, while fast-tracked obesity products — including a daily pill and a next-generation injection — may signal the boom isn't over. But even as Lilly climbs, the long shadow of insulin pricing controversies remains: Patients are still rationing, and there are tremendous affordability gaps on these drugs.

regulation

FDA leaders seize control of drug votes

The Food and Drug Administration's first "tumor board"-style votes under the new Commissioner's National Priority Voucher program were cast not by members of the agency's scientific review teams, but by a handpicked group of top agency leaders, STAT's Lizzy Lawrence reports. It's not clear yet what the outcome of the vote was.

The October vote excluded frontline reviewers from the voting roster, and instead included several high-profile figures internally.

It also marked a major departure from the agency's typical practice of investing this power in career officials, to avoid the perception of politics influencing the approval process. It's the latest example of how political influence is shaping FDA's scientific decision-making.

Read more.

REGULATION

FDA probes fatal antibody reaction to Adzynma

The FDA is investigating the case of a child who died after receiving Adzynma, an enzyme replacement therapy made by Takeda Pharmaceuticals for congenital thrombotic thrombocytopenic purpura. The child developed dangerous neutralizing antibodies, experiencing neurologic symptoms that worsened over 10 months of treatment, Reuters writes.

Regulators say they've received multiple post-marketing reports of antibody development — a safety signal not seen in trials and not reflected in current labeling. Takeda, which notified the agency in July, maintains there's no confirmed causal link, but the FDA is weighing additional regulatory action as it reviews whether this rare but potentially life-threatening immune response warrants stronger warnings or other steps.

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