25.07.2022 14:08:27

EMA's Committee Says Nulibry Is Authorizable For Treating MoCD Type A: Sentynl Therapeutics

(RTTNews) - BridgeBio Pharma, Inc. (BBIO) and Sentynl Therapeutics, Inc. on Monday said the EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended the authorization of NULIBRY (fosdenopterin) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

MoCD Type A is an ultra-rare and progressive condition, known to impact less than 150 patients globally with a median survival of four years.

Based on the CHMP recommendation, a decision on the authorization of NULIBRY by the European Commission is expected later this year.

NULIBRY was approved by the U.S. Food and Drug Administration in 2021 to reduce the risk of mortality in patients with MoCD Type A.

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