Kesimpta FDA approval for RMS: Novartis has bagged approval from the US Food and Drug Administration (FDA) for its blood cancer drug Kesimpta (ofatumumab, formerly OMB157) for the treatment of relapsing forms of multiple sclerosis (RMS).
The approval is for the use of the anti-CD20 monoclonal antibody (mAb) as a subcutaneous injection in clinically isolated syndrome, relapsing-remitting multiple sclerosis disease, and active secondary progressive disease, in adult patients.
Ofatumumab was first approved in 2009 by the FDA for the treatment of chronic lymphocytic leukemia (CLL). The approval was granted for the intravenous infusion of ofatumumab with a high dose, given by a healthcare provider.
According to Novartis, Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has demonstrated superior efficacy with a similar safety profile when compared with teriflunomide.
Kesimpta is now the first B-cell therapy that can be administered by the patient monthly once at home through the Sensoready autoinjector pen, said Novartis.
Marie-France Tschudin – President of Novartis Pharmaceuticals, commenting on Kesimpta FDA approval for RMS, said: “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.”
Kesimpta FDA approval for RMS has been granted by the FDA based on the findings of the phase 3 ASCLEPIOS 1 and 2 clinical trials, in which the B-cell therapy showed superiority compared to teriflunomide in substantially lowering the annualized relapse rate (ARR, primary endpoint), three-month confirmed disability progression (CDP), and the number of gadolinium-enhancing (Gd+) T1 and new or enlarging T2 lesions.
Commenting on Kesimpta FDA approval for RMS, Professor Stephen L. Hauser – Director of the UCSF Weill Institute for Neurosciences and co-chair of the steering committee for the ASCLEPIOS I and II studies, said: “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.
“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.”