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

RTTNews | 970 days ago

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.

Tags: AGIO

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Mild Rebound Tipped For Hong Kong Shares

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The Hong Kong stock market on Tuesday ended the eight-day winning streak in which it had surged almost 1,600 points or 7.1 percent. The Hang Seng Index now sits just beneath the 23,110-point plateau although it may tick back to the upside again on Wednesday.

RTTNews | 14 minutes ago

Australian Market Slightly Lower

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RTTNews | 1h 4min ago

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RTTNews | 2h 14min ago

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