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

RTTNews | 957 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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Thai Central Bank Cuts Rate By 25 Bps

Thai Central Bank Cuts Rate By 25 Bps

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Yen Falls On Trade Deal Hopes

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The Japanese yen weakened against other major currencies in the European session on Wednesday.

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Sensex, Nifty End Choppy Session Marginally Lower

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German stocks are up on Wednesday, rising for a seventh straight session, amid easing trade tensions, and on fairly encouraging quarterly results from big name companies. Investors are also digesting a slew of economic data.

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