Pfizer, OPKO Health: EMA to Review Somatrogon for Growth-Hormone Deficiency
February 26 2021 - 7:45AM
Dow Jones News
By Colin Kellaher
Pfizer Inc. and OPKO Health Inc. on Friday said the European
Medicines Agency validated for review their marketing authorization
application for somatrogon, a once-weekly human-growth hormone for
pediatric patients with growth-hormone deficiency.
New York drug maker Pfizer said somatrogon, if approved, would
help reduce the burden of daily growth-hormone injections, adding
that it expects a decision from the European Commission in
2022.
Pfizer and OPKO, a Miami healthcare-services company, signed a
worldwide agreement in 2014 to develop and commercialize somatrogon
for growth-hormone deficiency. The U.S. Food and Drug
Administration in January accepted for review the companies'
application for somatrogon.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 26, 2021 07:30 ET (12:30 GMT)
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