Eli Lilly's Foundayo receives positive EMA recommendation for obesity and diabetes

The European Medicines Agency (EMA) has issued a positive opinion via its Committee for Medicinal Products for Human Use (CHMP) regarding Eli Lilly’s oral medication, Foundayo (orforglipron). The drug is intended for the treatment of obesity and type 2 diabetes in adults.

Foundayo is a GLP-1 receptor agonist delivered in a once-daily tablet. Clinical studies involving 4,740 participants over 72 weeks showed weight reductions ranging from 5% to 11% depending on the dosage, compared to 2% to 2.5% in the placebo group. Common side effects reported include gastrointestinal issues such as nausea, vomiting, and diarrhea.

While the EMA's recommendation is a critical step toward European market expansion, it does not constitute immediate authorization. The final decision rests with the European Commission. Following approval, individual EU member states will need to negotiate pricing and reimbursement protocols.