Agios Pharma's PYRUKYND Approved In UAE For Alpha- And Beta-Thalassemia

Agios Pharmaceuticals

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(RTTNews) - Biopharmaceutical company Agios Pharmaceuticals, Inc. (AGIO) announced Monday that the Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) has approved PYRUKYND (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia.

With this approval, PYRUKYND becomes the only medicine approved in the UAE for this patient population.

The EDE approval of PYRUKYND in thalassemia is based on results from the global, randomized, double-blind, placebo-controlled ENERGIZE and ENERGIZE-T Phase 3 trials in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia, respectively.

In 2024, Agios entered into a distribution agreement with NewBridge Pharmaceuticals to advance regulatory filings and commercialization of PYRUKYND in the Gulf Cooperation Council (GCC), which includes Saudi Arabia, the UAE, Kuwait, Qatar, Oman, and Bahrain.

PYRUKYND is also approved for adults with PK deficiency in the U.S. and Europe, and a marketing application for PYRUKYND in thalassemia is currently under review by the European Commission. In the U.S., mitapivat is approved for adults with thalassemia under the brand name AQVESME (mitapivat).