A panel that advises the European drugs regulator has supported an approval for AstraZeneca Plc’s diabetes drug combination.
The European Medicines Agency said on Friday that the Committee for Medicinal Products for Human Use backed AstraZeneca’s combination of saxagliptin and dapagliflozin. (bit.ly/20JOyWA)
The recommendation comes seven months after the U.S. Food and Drug Administration denied an approval to the treatment, seeking more data.
The components of the combination are currently sold separately for the treatment of type 2 diabetes under the Onglyza and Farxiga brand names.
AstraZeneca said earlier on Friday that U.S. regulators would not approve its new drug for high potassium levels at present due to a manufacturing issue.
The company’s shares were down 1 percent at 3973.5 pence on the London Stock Exchange at 1122 GMT.
(Reporting by Mamidipudi Soumithri in Bengaluru; Editing by Kirti Pandey)