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.
More articles on pharmacy:
Uber breaks into prescription delivery business
5 drugmakers tell hospitals they plan to withhold 340B discounts
AstraZeneca slammed by advocacy group over drug discount denials
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.