USFDA declines to approve Pfizer-OPKO

Pfizer Inc said on Friday the U.S. health regulator had refused to approve a treatment for growth hormone deficiency in children that it had developed with partner OPKO Health Inc (OPK.O).

Pfizer’s statement did not mention the reason for the U.S. Food and Drug Administration (FDA) decision in its full response letter.

“We will work closely with the FDA to determine the best path forward to bring this important once-weekly treatment option to pediatric patients with growth hormone deficiency and their families,” said Brenda Cooperstone, Director of Rare Disease Development, Pfizer Global Product Development. Reuters