Novartis gets FDA OK on new indication for Kesimpta

Patients with relapsing forms of multiple sclerosis have a new treatment that can be self-administered at home.

The Food and Drug Administration has approved Novartis’ Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

"At Novartis, we challenge treatment paradigms and strive to offer the best treatment choice for patients," said Marie-France Tschudin, Novartis Pharmaceuticals president. "When treating patients with RMS, Kesimpta is a meaningful treatment option that delivers both high efficacy and safety with the ability for patients to have more freedom in managing their disease. The development of Kesimpta is a great example of our commitment, knowledge and understanding of multiple sclerosis, which enabled us to identify a targeted treatment that can significantly improve patient outcomes and experience."

"This approval is wonderful news for patients with relapsing multiple sclerosis. In the key clinical studies, this breakthrough treatment produced a profound reduction in new brain lesions, reducing relapses and slowing underlying disease progression," said Professor Stephen Hauser, director of the UCSF Weill Institute for Neurosciences and co-chair of the steering committee for the ASCLEPIOS I and II studies. "Through its favorable safety profile and well-tolerated monthly injection regimen, patients can self-administer the treatment at home, avoiding visits to the infusion center."

"Multiple sclerosis is a complex disease, and response to disease modifying treatment will vary among individuals," said Bruce Bebo, executive vice president of Research at the National MS Society. "This makes it important to have a range of treatments available with different mechanisms of action and routes of administration. We are pleased to have an additional option approved for the treatment of relapsing forms of MS."

Ofatumumab was first approved by the FDA in 2009 for the treatment of chronic lymphocytic leukemia  as an intravenous infusion with a high dose, administered by a healthcare provider.