Pierre Fabre’s overactive bladder medication won approval in Europe on Friday as a panel of experts at the European Medicines Agency separately recommended 10 others for first-time nods.
The approval of Pierre Fabre’s Obgemsa comes two years after the French pharma acquired rights to commercialize the product in Europe from Urovant. Pierre Fabre said in its announcement Friday that the condition affects more than 70 million European adults.
Separately, experts at the European Medicines Agency recommended that 10 new drugs should be approved, including Moderna’s RSV shot, mResvia, and Merck’s pulmonary arterial hypertension med, Winrevair.
The Committee for Medicinal Products for Human Use (CHMP) also recommended 11 new label expansions. One application, Teva’s generic anticoagulant med dabigatran etexilate, was withdrawn for commercial reasons, the company said in a letter.
Among the more notable positive recommendations issued Friday was a greenlight for odronextamab, Regeneron’s third-line treatment for relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma (DLBCL). The treatment was rejected by the FDA in late March due to the enrollment status of its confirmatory trials.
“Enrollment in the dose-finding portion has begun, but the [complete response letters] indicate that the confirmatory portions of these trials should be underway and that the timelines to completion be agreed prior to resubmission,” Regeneron wrote at the time.
The FDA has begun to more stringently monitor confirmatory trial enrollment as a condition of accelerated approvals. The CHMP’s opinion was based largely on response rate data from a Phase 2, open-label study.
The FDA and CHMP were aligned on AbbVie and Genmab’s bispecific antibody, Tepkinly. The US regulatory body granted accelerated approval for the treatment on Wednesday in the same indication that Regeneron is pursuing with odronextamab and for which CHMP issued a positive opinion on Friday.
“This positive opinion recognizes the unmet need in the European Union for individuals with relapsed or refractory follicular lymphoma, following failure of other therapies,” said AbbVie’s hematology therapeutic area head Mariana Cota Stirner in a statement.
Additional recommendations for new medicines include:
- Johnson & Johnson’s Balversa for adults with locally advanced unresectable or metastatic urothelial carcinoma
- ARS Pharmaceuticals’ Eurneffy for the treatment of allergic reactions and idiopathic or exercise induced anaphylaxis
- Roche’s Piasky as a treatment for paroxysmal nocturnal hemoglobinuria
- Lilly’s PET imaging agent, Tauvid