- The FDA has issued Pfizer (NYSE:PFE) and OPKO Health (NASDAQ:OPK) a Complete Response Letter for their Biologics License Application ("BLA") for somatrogon.
- OPKO shares are down 9% in after-hours trading.
- The candidate is a once-weekly, long-acting recombinant human growth hormone for the treatment of pediatric growth hormone deficiency.
- Pfizer is examining the agency's comments and will determine what path to take with the agency.
- Somatrogon is already approved in Japan, Canada, and Australia under the brand name Ngenla.
- In December, the European Medicine Agency's Committee for Medicinal Products for Human Use issued a positive opinion on somatrogon. A decision from the European Commission is expected early this year.
The FDA extended a decision on the BLA back in September.