Regulators at the U.S. Food and Drug Administration (FDA) are reportedly weighing whether to sharply accelerate early-stage review steps for Eli Lilly and Co.’s (NYSE:LLY) experimental oral weight-loss treatment, orforglipron.
The initiative is part of the National Priority Voucher program, launched in June, which aims to streamline decisions for products tied to significant public-health or national-security needs.
Citing internal documents, Reuters noted that the FDA Commissioner's Office has urged staff to cut the standard 60-day filing check, used to confirm whether an application is complete, to as little as one week for Lilly's drug and others in a new expedited pathway.
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Following internal pushback, the Commissioner's Office signaled it may instead shorten filing reviews to two or three weeks, depending on the complexity of the application.
Potential Impact On Approval Timeline
It remains unclear whether any change will be adopted, but a compressed timeline could move Lilly's target decision date to late March, well ahead of the current May 20 goal set by reviewers, Reuters reported.
Rival Novo Nordisk A/S (NYSE:NVO) is expected to launch its own weight-loss pill within weeks (in December or January), adding to the urgency.
The agency requires companies in the voucher program to provide manufacturing data and draft labeling 60 days before final submission. By law, reviewers must complete the final review within two months, creating a total expected review time of roughly six months.
Ozempic Launches In India At $24 A week
Separately, Novo Nordisk launched Ozempic in India on Friday, setting a weekly price of $24.35 for the 0.25 mg dose as it moves to capture growth in one of the world's largest diabetes and obesity markets.
Reuters reported the drug will be sold in pen formats across 0.25 mg, 0.5 mg, and 1 mg strengths, with monthly pricing of 8,800 rupees, 10,170 rupees, and 11,175 rupees, respectively. Each pen includes four weekly doses.
Analysts expect these prices to set the benchmark for semaglutide generics slated to arrive next quarter.
India is the second-largest market for type 2 diabetes after China, making it a key expansion opportunity for Novo Nordisk.
Major Indian drugmakers, including Sun Pharma, Cipla, Dr. Reddy's Laboratories Ltd. (NYSE:RDY), and Lupin, are racing to bring semaglutide generics to market.
LLY Price Action: Eli Lilly shares were up 0.87% at $1018.14 during premarket trading on Friday, according to Benzinga Pro data.
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