AstraZeneca's cancer, heart drugs gets EMA panel nod for expanded use in EU
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A panel of the European Medicines Agency (EMA) recommended the expanded approval of AstraZeneca's (NASDAQ:AZN) medicines Edistride, Forxiga and Enhertu.
The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted an extension to an existing indication of Edistride (dapagliflozin) and Forxiga (whose active substance is also dapagliflozin) to treat adults with symptomatic chronic heart failure. The earlier indication for both was limited to treatment of adults with symptomatic chronic heart failure with reduced ejection fraction.

Edistride and Forxiga are also approved in the EU to treat certain patients with type 2 diabetes; and chronic kidney disease.
The CHMP also gave a greenlight to expanded use of AstraZeneca and Daiichi Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Enhertu as monotherapy for treating adult patients with unresectable or metastatic HER2âlow breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Enhertu (trastuzumab deruxtecan) is already approved to treat certain patients with breast cancer, and a type of gastric cancer.