""FDA policymakers have tried to come up with ideas to speed important products to market. ... It is in part directed to achieving some of the (Trump) Administration's goals," said Chad Landmon, chair of Polsenelli's patent and FDA practice."
""We think orforglipron is a prime candidate for this pilot program as it treats a high-burden chronic condition and can be priced at parity," Jefferies analyst Akash"
The FDA launched the Commissioner's National Priority Voucher to allow one- to two-month reviews for qualifying drugs, replacing the standard 10-month review. Orforglipron, an oral GLP-1 obesity candidate from Eli Lilly, could meet the criteria due to its oral form, potential parity pricing, and U.S. manufacturing expansion. Oral competition could lower costs compared with expensive injectable GLP-1 drugs that impose heavy spending pressures on employers and insurers amid roughly 40% adult obesity. A one-quarter earlier launch is estimated to add about $1 billion in revenue. Novo Nordisk's oral GLP-1 is also under FDA review with a Q4 decision expected. Lilly declined to comment.
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