The recommendation by EMA’s Committee for Medicinal Products for Human Use (CHMP) can be a shot in the arm for drug companies as they are normally endorsed by the European Commission.
The oral treatment for Type II diabetes, which will be sold under the brand name Steglatro, belongs to a class of drugs known as SGLT2 inhibitors, which help patients expel excess glucose through urine.(bit.ly/2FjyqXs)
In December, Merck and Pfizer won approval from the U.S. Food and Drug Administration for Steglatro 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