CDER Reports ‘Strong Year’ for Novel Drug Approvals

CDER Director Janet Woodcock flagged 2019 as a strong year for novel drug approvals, although the total dipped to 48 from the ten-year record of 59 for 2018.

Twenty-one approvals were for orphan drugs, such as Daiichi Sankyo’s Turalio (pexidartinib) for adults with non-cancerous tumors.

“In the past eight years, CDER has approved more than twice as many orphan drugs than we did in the previous eight years,” Woodcock said. 

Twenty of the novel drugs approved in 2019 were first-in-class approvals, such as Janssen’s bladder cancer treatment Balversa (erdafitinib) and Sage Therapeutics’ post-partum depression treatment Zulresso (brexanolone).