Novo Nordisk Denecimig review extended by FDA

The US Food and Drug Administration (FDA) has extended its review of Denecimig, a drug candidate from Novo Nordisk intended to treat Hemophilia A. The agency has not provided a new specific timeline for a regulatory decision.

Novo Nordisk stated that the delay is due to ongoing work at a production facility and is not related to the clinical efficacy or safety of the drug. The company maintains its expectation to launch Denecimig in the United States during the first half of 2027.

Denecimig is a bispecific antibody designed to prevent bleeding in patients with Hemophilia A. It is administered via subcutaneous injection with dosing schedules ranging from once weekly to once monthly.