Biohaven Gets FDA Fast-Track Tag for Taldefgrobep in Spinal Muscular Atrophy

By Colin Kellaher

Biohaven Ltd. on Tuesday said the U.S. Food and Drug Administration granted fast-track designation to taldefgrobep alfa for the treatment of spinal muscular atrophy, a rare and progressively debilitating motor-neuron disease.

The New Haven, Conn., clinical-stage biopharmaceutical company said taldefgrobep has the potential to be a novel therapy to be used in combination with disease-modifying therapies to enhance muscle function by blocking activity of myostatin, naturally occurring protein that limits skeletal muscle growth.

The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.

Biohaven previously received FDA orphan-drug designation, which gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S., for taldefgrobep in spinal muscular atrophy.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

February 21, 2023 08:01 ET (13:01 GMT)

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