FDA approves Eli Lilly’s Foundayo to reduce excess body weight

The Food and Drug Administration approved Foundayo, or orforglipron, marking the fifth approval under the Commissioner’s National Priority Voucher pilot program, the agency stated. Foundayo is approved for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. “Issued 50 days after filing – and 294 days before the application’s PDUFA date of January 20, 2027 – this decision represents a historic milestone as the first new molecular entity approved under the program. It is also the fastest approval of an NME since 2002,” the FDA said. The FDA granted the approval to Eli Lilly (LLY).