For the fifth consecutive year, Congress has adjourned and allowed Medicare cuts,” said Bruce A. Scott, MD, president of the AMA.

Vasomotor symptoms are a common problem in women with HR-positive breast cancer receiving anti-cancer therapy.

The application is supported by data from the randomized, double-blind, placebo-controlled phase 3 Vivacity-MG3 study.

The sNDA is supported by data from the phase 3 ENERGIZE and ENERGIZE-T studies, which evaluated mitapivat vs placebo in patients with NTD and TD alpha- or beta-thalassemia, respectively.