Novartis has received approval from the US Food and Drug Administration (FDA) for Kesimpta (ofatumumab, formerly OMB157) to treat adults with relapsing forms of multiple sclerosis (RMS).
The drug is for use as a subcutaneous injection and its indication for RMS includes treatment of clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
Kesimpta is a targeted B-cell therapy, self-administered once per month at home using the Sensoready autoinjector pen.
Novartis Pharmaceuticals president Marie-France Tschudin 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.”
FDA approval of Kesimpta comes from data pf Phase III ASCLEPIOS I and II clinical trials, where the drug showed superiority compared to teriflunomide with a significant decrease in the annualised relapse rate (primary endpoint).
Data also showed superiority in decreasing three-month confirmed disability progression (CDP), as well as the number of gadolinium-enhancing (Gd+) T1 and new or enlarging T2 lesions.
In the US, the drug should be available early next month, with other regulatory filings ongoing globally, with European regulatory approval expected by the second quarter of next year.
Initially, the FDA approved ofatumumab in 2009 as an intravenous infusion to treat chronic lymphocytic leukaemia (CLL).
In April, the FDA granted regenerative medicine advanced therapy (RMAT) designation to Novartis’ Kymriah (tisagenlecleucel) to treat relapsed or refractory (r / r) follicular lymphoma (FL).