Agios Says CHMP Adopts Positive Opinion For PYRUKYND To Treat Pyruvate Kinase Deficiency In Adults

RTTNews | 1073 days ago
Stocktwits
Agios Says CHMP Adopts Positive Opinion For PYRUKYND To Treat Pyruvate Kinase Deficiency In Adults

(RTTNews) - Agios Pharmaceuticals, Inc. (AGIO) announced Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on September 15, 2022, recommending the granting of a marketing authorization for PYRUKYND (mitapivat) for the treatment of pyruvate kinase (PK) deficiency in adult patients.

PK deficiency is a rare, debilitating, lifelong hemolytic anemia. PYRUKYND is a first-in-class, oral PK activator that was recently approved by the U.S. Food and Drug Administration (FDA).

If approved by the European Commission (EC), PYRUKYND will be the first approved disease-modifying therapy for European patients with PK deficiency.

PYRUKYND was previously granted orphan drug designation by the EMA.

The positive CHMP opinion was based on results from two pivotal studies, ACTIVATE and ACTIVATE-T, conducted in not regularly transfused and regularly transfused adults with PK deficiency, respectively.

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Indonesia Stock Market May End Losing Streak On Monday

Indonesia Stock Market May End Losing Streak On Monday

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RTTNews | 18 minutes ago
Australian Market Notably Higher

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RTTNews | 19 minutes ago
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RTTNews | 33 minutes ago
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RTTNews | 1h 18min ago
Singapore Stock Market May See Additional Support On Monday

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RTTNews | 1h 48min ago
Malaysia Stock Market Likely To Crack Resistance At 1,600 Points

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RTTNews | 2h 18min ago
Japan Stock Market May Extend Friday's Gains

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RTTNews | 2h 34min ago
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