EMA recommends authorization for two new oral medications

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for two new oral medications.

First, the CHMP recommended the authorization of Foundayo (orforglipron), an oral GLP-1 receptor agonist developed by Eli Lilly Nederland B.V. The drug is intended for adults with obesity or overweight who have at least one weight-related health condition, as well as for adults with type 2 diabetes whose blood glucose is not sufficiently controlled by diet and exercise. As a non-peptide small molecule, orforglipron works by activating the GLP-1 receptor to reduce appetite, increase satiety, and improve insulin response.

Second, the CHMP gave a favorable opinion for didaraxonrasib, an oral therapy for adults with metastatic pancreatic adenocarcinoma who have previously undergone chemotherapy. Evaluated under the Cancer Medicines Pathfinder pilot program, the drug aims to address a high unmet medical need in patients with severe prognosis. Following the CHMP opinion, the medication must receive formal marketing authorization from the European Commission before national authorities, such as Italy's AIFA, can negotiate pricing and reimbursement.