FAST LANE

New Weight-Loss Pills Could Arrive Sooner Than We Think

The timeline for a much-anticipated medication may be getting a speed boost.

Millions of Americans have successfully lost weight with semaglutides, the game-changing class of drugs that includes Ozempic, Mounjaro, and Wegovy. Still, many others are holding out for GLP-1 medication to arrive in pill form—and they may not have to wait much longer.

Orforglipron, a GLP-1 agonist administered as a pill, is developed by pharmaceutical giant Eli Lilly and is among the most highly anticipated oral medicines. (Eli Lilly is also the drugmaker behind Mounjaro, a semaglutide touted by Amy Schumer and Eric Stonestreet, among other celebrities.) The medication, which has shown promising results in clinical trials for weight management, is currently under review by the U.S. Food and Drug Administration (FDA).

While similar drugs are in the review pipeline, Eli Lilly may find its pills pulling away from the pack, thanks to pressure on reviewers from both the drug giant and the FDA to hasten their pace, according to a Reuters report on December 12.

GLP-1 agonists are a class of medication prescribed to treat obesity and type 2 diabetes. Since 2021, demand for semaglutide and related compounds has soared. But as consumers seek to avoid the high costs and side effects associated with GLP-1 jabs, pharmaceutical companies are clamoring to develop effective oral medications.

FDA Deputy Chief Medical Officer Mallika Mundkur, the report said, is pushing to fast-track the agency’s evaluation of Orforglipron and wants to reduce the review time from 60 days to a single week.

Due to the complexity of the drug, the drastically slashed schedule may be too ambitious for Orforglipron’s review, with the one-week request receiving “internal pushback,” according to Reuters. Instead, two to three weeks, still less than half of the original timeline, may be considered more realistic.

Eli Lilly’s pill was set to have a decision by May 20, but now could be decided upon as early as the end of March if a new schedule is approved.

Orforglipron was one of six drugs announced as part of the latest batch of the FDA’s National Priority Voucher pilot program, announced in November, which aims to shorten review timelines from 10 to 12 months to just one or two. Other drugs in the program include medications for lung cancer, rectal cancer, tuberculosis, sickle-cell disease, and a high-dose version of Novo Nordisk’s Wegovy, another obesity-related drug.

Orforglipron isn’t the only obesity pill that made headlines this week. On December 9, Pfizer announced a $2.1 billion deal with the Chinese company YaoPharma to license its oral weight-loss medication, which is still in development.

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Carina HsiehReporter, Looker

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