- A panel of the European Medicines Agency (EMA) recommended granting approval to Viatris ( NASDAQ: VTRS ) drug Dapagliflozin Viatris to treat type 2 diabetes mellitus, heart failure and chronic kidney disease.
- Dapagliflozin Viatris is a generic of AstraZeneca's ( NASDAQ: AZN ) Forxiga, which has been authorized in the EU since November 2012. The drug is marketed as Farxiga in the U.S.
- The European Commission, which generally follows the opinion of the EMA's Committee for Medicinal Products for Human Use (CHMP), will now decide on the marketing authorization of the drug.
For further details see:
Viatris' Farxiga generic gets EMA committee's backing for approval in EU