After some lengthy delays, Sanofi gets the FDA's OK for a rare disease drug

John Carroll

Editor & Founder

More than 2 years after Sanofi claimed an early pivotal win for its newly-acquired rare disease drug sutimlimab, and more than a year since the FDA handed back their initial application due to unexplained manufacturing issues, the pharma giant has bounced back with the approval late on Friday.

Sanofi, which is undergoing both a facelift as well as a restructuring under CEO Paul Hudson, cheered the news that regulators in the US have cleared the drug for cold agglutinin disease, an affliction that triggers a rare form of anemia in patients.

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After some lengthy delays, Sanofi gets the FDA's OK for a rare disease drug

John Carroll

Editor & Founder

Unlock this article instantly by becoming a free subscriber.

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Af­ter some lengthy de­lays, Sanofi gets the FDA's OK for a rare dis­ease drug

Editor & Founder

Unlock this article instantly by becoming a free subscriber.

Adicet Bio

Redwood City, CA, USA

After some lengthy delays, Sanofi gets the FDA's OK for a rare disease drug