EU regulator’s advisory panel backs AstraZeneca diabetes drug


Bengaluru: A panel that advises the European drugs regulator has supported an approval for AstraZeneca Plc’s diabetes drug combination.

The European Medicines Agency (EMA) said on Friday that the Committee for Medicinal Products for Human Use backed AstraZeneca’s combination of saxagliptin and dapagliflozin.

The recommendation comes seven months after the US 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 US 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% at 3973.5 pence on the London Stock Exchange at 1122GMT.

Meanwhile, Gilead Sciences Inc.’s new hepatitis C drug combination, which shares an active ingredient with blockbuster Sovaldi, was also recommended for marketing approval by EMA.

EMA’s Committee for Medicinal Products for Human Use said it recommended approval of the combination of sofosbuvir and velpatasvir. Sofosbuvir is at the centre of a patent battle between Gilead and Merck and Co Inc.

Sovaldi generated $1.28 billion of sales in the first quarter for Gilead.