Keeping Track: US FDA Clears Another CAR-T And Another Novel ADHD Drug; Submissions Blossom

The US Food and Drug Administration’s most recent novel approvals sound familiar themes. Bristol Myers Squibb Company's Abecma (idecabtagene vicleucel) is the second novel chimeric antigen receptor T-cell (CAR-T) therapy to clear the Center for Biologics Evaluation and Research in 2021. Supernus Pharmaceuticals, Inc.'s Qelbree (viloxazine) is the second novel therapy for attention deficit hyperactivity disorder approved by the Center for Drug Evaluation and Research this year.

While Qelbree is the 15th novel approval from CDER in 2021, Abecma is only the second CBER original approval. BMS holds a monopoly on those CBER approvals, thanks to the company’s acquisitions in the CAR-T space