A pill version under development of Novo Nordisk’s (NVO) GLP-1 Wegovy (semaglutide) and Eli Lilly’s (LLY) experimental oral GLP-1 orforglipron are among the second round of recipients of the FDA Commissioner’s National Priority Review program that speeds up agency review of drug applications.
Novo submitted an application to the FDA for oral Wegovy in April and was expecting a decision by year end.
In September, it was also reported that the Danish pharma would be seeking approval of a high-dose version of the existing injectable Wegovy.
Lilly has yet to submit an application for orforglipron in obesity, but that is expected by the end of 2025. A separate application for the drug in type 2 diabetes is projected in 2026.
In September, data from a phase 3, head-to-head study of orforglipron vs. oral semaglutide released by Lilly showed greater weight loss with the former.
The development for Novo and Lilly came the same day the White House announced major drug-pricing deals with both drugmakers for their GLP-1 drugs
Other treatments that received priority review vouchers Thursday are Boehringer Ingelheim’s Hernexeos (zongertinib) for HER2 lung cancer; Johnson & Johnson’s (JNJ) Sirturo (bedaquiline) for drug-resistant tuberculosis in young children; GSK’s (GSK) Jemperli (dostarlimab) for rectal cancer; and Vertex Pharmaceuticals (VRTX)/CRISPR Therapeutics (CRSP) gene therapy Casgevy (exagamglogene autotemcel) for sickle cell disease.