A European Medicines Agency panel recommended granting marketing approval to a diabetes drug developed by Merck & Co and Pfizer Inc.
The recommendation by EMA’s Committee for Medicinal Products for Human Use can be a shot in the arm for drug companies as they are normally endorsed by the European Commission.
In December, Merck and Pfizer won approval from the U.S. Food and Drug Administration for Stellato as a single therapy and in fixed-dose combinations with Merck’s diabetes drug Januvia or with metformin, an older generic treatment typically given to newly diagnosed patients.
Diabetes, characterized by elevated blood sugar levels, can severely damage organs, including eyes and kidneys, and significantly raises the risk of heart attack and stroke.
As type II diabetes progresses, many patients need additional treatments to better control blood sugar levels.
(Reporting by Radhika Rukmangadhan in Bengaluru; Editing by Anil D’Silva)