The agency based its approval on two clinical studies proving the drug’s efficacy in reducing MS relapses, treating brain lesions and obstructing disease progression.
Novartis expects to make Kesimpta, a B-cell therapy patients can self-administer with an injector pen, available in the U.S. by early September. The Swiss drugmaker also said it expects European regulatory approval in 2021’s second quarter.
The drug was first approved by the FDA in 2009 to treat chronic lymphocytic leukemia as a high-dose intravenous infusion administered by a healthcare provider. It was then explored in a new development program for MS treatment, as B-cells are are often play an important part in the development of autoimmune diseases.
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