AstraZeneca Gets EU Committee Recommendation For Approval Of Heart Failure, Lung Cancer Treatments

The United Kingdom-based pharmaceutical company, AstraZeneca Plc AZN received The Committee for Medicinal Products for Human Use (CHMP) recommendation for two of its treatments, Forxiga and Trixeo Aerosphere.

What Happened: The Committee for Medicinal Products for Human Use (CHMP), a segment of the European Medicines Agency (EMA),  approved Forxiga for treatment in some cases of heart failure, whereas Trixeo Aerosphere received approval for use in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD), which is better known as the "smoker’s lung."

AstraZeneca said Forxiga (dapagliflozin) received the CHMP recommendation based on results from the DAPA-HF Phase III trials, published in the New England Journal of Medicine. Whereas, in the case of Trixeo Aerosphere, the CHMP recommendation purportedly followed the results from the ETHOS Phase III Trial supported by data from the KRONOS Phase III trial.

Both clinical trial programs for Trixeo Aeropshere included over 15,500 patients globally participating in 11 trials. Forxiga’s clinical trials cover 35 trials, including completed and ongoing trials, with close to 35,000 patients.

Why Does It Matter: In the U.S., Forxiga is known as Farxiga, and is a U.S. Food and Drug Administration-approved treatment for HfrEF patients.

Trixeo Aerosphere also has regulatory approvals in the U.S., Japan, and China under the brand Breztri Aerosphere for treating patients with COPD.

Price Action: AZN Stock was trading 1.45% higher at $53.80 during pre-market hours.

Photo by Kimivanil on Wikimedia