Posted by Michael Wonder on 13 May 2026
Agios submits sNDA to FDA for US accelerated approval of mitapivat in sickle cell disease
12 May 2026 - Agios Pharmaceuticals today announced the submission of its supplemental new drug application to the US FDA for the US accelerated approval of mitapivat, an oral pyruvate kinase activator, in sickle cell disease.
The submission follows agreement with the FDA on the confirmatory clinical trial, which is required under the accelerated approval pathway.
