UK Approves Givinostat (Duvyzat) for Duchenne Muscular Dystrophy Treatment

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The MHRA’s conditional approval allows givinostat to be used in patients with DMD who are six years of age and older, and it is applicable to all genetic variants of the condition. This decision follows the U.S. Food and Drug Administration’s (FDA) approval of givinostat earlier this year.

Givinostat conditionally approved to treat patients with Duchenne muscular dystrophy (DMD).

In a significant development for patients with Duchenne muscular dystrophy (DMD), the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a conditional marketing authorisation for the medicine givinostat, also known as Duvyzat.

This approval, announced on 20 December 2024, marks a crucial step forward in the treatment of this debilitating genetic disorder.

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Givinostat is a nonsteroidal drug indicated for the treatment of patients aged 6 years of age and older with all genetic variants of DMD. [Read more: What is Duvyzat (Givinostat)?]

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SourceMHRA
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