FDA declines to OK Pfizer-Opko growth hormone deficiency treatment

 Pfizer Inc PFE.N said on Friday the U.S. health regulator has declined to approve the treatment for growth hormone deficiency in children that it developed with partner OPKO Health Inc OPK.O.

Pfizer's statement did not mention a reason for theU.S. Food and Drug Administration's (FDA) decisionin its complete 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 growth hormone deficiency patients and their families," said Brenda Cooperstone, chief development officer of Rare Disease, Pfizer Global Product Development.

Pfizer has submitted applications to regulators of various countries and Japan earlier this week approved the drug, which will be sold under the brand name Ngenla.

Growth hormone deficiency is a rare disorder where the pituitary gland does not produce enough growth hormone to stimulate the body to grow. It is characterized by abnormally short height and affects one in about 4,000 to 10,000 children globally.

https://www.nasdaq.com/articles/u.s.-fda-declines-to-approve-pfizers-growth-hormone-deficiency-treatment