Obesity
A cheatsheet for the landmark Wegovy study
Any day now, Novo Nordisk will disclose data from a first-of-its kind study of the obesity medicine Wegovy. The results have massive implications for a whole class of newfangled obesity medicines, potentially boosting demand, streamlining insurance coverage, and changing how society thinks about weight loss.
The study is called Select, the first large, randomized trial to test whether long-term treatment with a weight loss drug can meaningfully improve patients' cardiovascular health. Novo is testing Wegovy, a weekly injection also sold under the brand name Ozempic for type 2 diabetes, against placebo in the five-year study.
At stake is whether Wegovy can grow from a trendy pharmaceutical product into a mainstay of modern medicine, and the results will help determine the fates of competing treatments from Eli Lilly, Pfizer, Amgen, and others.
STAT put together a guide to understand the study and its implications, which you can read here.
mRNA
Moderna finally makes its way to China
After months of investor speculation and rumored negotiation, Moderna has signed a deal to make its mRNA vaccines in China, a potential boon to the company's long-term profitability.
Moderna said in a statement yesterday that it had entered into an agreement to develop and manufacture medicines in China that would not be exported. Yicai, a local news outlet, reported Moderna would invest as much as $1 billion into the effort. Moderna's share price, down by nearly a third this year, rose as much as 3% on the news.
The details — including just when Moderna might see a return on its investment — remain unclear, but the fact of the deal would seem to signal a shift on the part of Beijing, which favored locally developed Covid-19 vaccines over those from Moderna and its rivals at BioNTech. And that's a welcome change for Moderna, which faces an uncertain financial future after declining demand for Covid boosters decimated its revenue.
Alzheimer's
Happy Leqembi day
At some point today, the FDA will hand down a decision on Eisai's application to win full approval for Leqembi, the first treatment for Alzheimer's disease to show a clear effect on cognitive decline.
Leqembi, co-marketed with Biogen, is widely expected to win approval, but don't expect that to be a starter pistol for blockbuster sales. As STAT reported in June, physicians around the country have been scrambling to prepare for Leqembi's approval, working under the assumption that Medicare will lift its restrictions on the drug and allow for wider prescribing.
The process of actually getting people on the drug is likely to be complex, neurologists have said, involving a series of tests that may or may not be covered by insurance and gathering data for a patient registry whose details still remain unclear. All of which is to say Leqembi's rollout is likely to be gradual and not without complications.
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