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Novartis Says EU Regulator Panel Recommends Marketing Authorization for Fabhalta to Treat Blood Disorder
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Novartis Says EU Regulator Panel Recommends Marketing Authorization for Fabhalta to Treat Blood Disorder
Mar 22, 2024 7:24 AM

09:55 AM EDT, 03/22/2024 (MT Newswires) -- Novartis ( NVS ) said Friday the European Medicines Agency's Committee for Medicinal Products for Human Use is recommending a marketing authorization for Fabhalta to treat people with paroxysmal nocturnal hemoglobinuria, a rare blood disorder.

The committee's positive opinion was based on results from a late-stage trial showing "superior hemoglobin improvement in the absence of transfusions with Fabhalta compared to anti-C5 therapy," Novartis ( NVS ) said.

After the committee's recommendation, the European Commission will now make a final decision in about two months, Novartis ( NVS ) said.

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