AZ and GSK drugs given approval for marketing across Europe

The European Medicines Agency (EMA) has approved two drugs for marketing across the European Union – AstraZeneca’s Xigduo and GlaxoSmithKline’s Tivicay.

Xigduo (dapagliflozin and metformin hydrochloride) is a combination treatment for type 2 diabetes while Tivicay (dolutegravir) is an HIV antiretroviral.

The European Commission’s decisions were announced by the two pharma giants this week.

“Metformin has long been a standard of diabetes care, and with the Xigduo approval, we now have an SGLT2 inhibitor and metformin combination product representing an innovative option for treating adults with type 2 diabetes.”

Elisabeth Bjork, head of late-phase cardiovascular and metabolic development, AstraZeneca.

“We continue to find measurable clinical differences among the treatments now available for use in combination therapy to combat HIV.

“Using the clinical data for Tivicay, doctors and people living with HIV can fully consider the effectiveness against the virus and the side effect profile that Tivicay may bring.”

John Pottage, chief medical officer, ViiV Healthcare, GlaxoSmithKline



Related news:

AstraZeneca’s diabetes drug Xigduo approved in Europe (Reuters).

Glaxo’s once-a-day HIV pill given go-ahead in Brussels (The Times).

Reference links:

Xigduo (dapagliflozin and metformin hydrochloride) approved in the European Union for type 2 diabetes (AstraZeneca press release).

ViiV Healthcare’s new HIV medicine Tivicay (dolutegravir) is approved in Europe (GlaxoSmithKline press release).

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