Novartis has received the US Food and Drug Administration (FDA) approval for Kesimpta (ofatumumab) subcutaneous injection to treat a type of multiple sclerosis (MS).

The FDA approval indicated Kesimpta for relapsing forms of MS (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.

Kesimpta is an anti-CD20 monoclonal antibody (mAb), used as a precisely dosed and delivered B-cell therapy, self-administered once monthly at home using the Sensoready autoinjector pen.

The drug was originally developed by Genmab and was licensed to GlaxoSmithKline (GSK), from where Novartis has secured the rights for Kesimpta in all indications, in December 2015.

The company claimed that Kesimpta is the first B-cell therapy, capable of being self-administered, and has shown superior efficacy with a similar safety profile compared with teriflunomide.

Novartis Pharmaceuticals president Marie-France Tschudin said: “At Novartis, we challenge treatment paradigms and strive to offer the best treatment choice for patients. 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 eliminates need for any premedication

Conventional B-cell treatments, available in hospitals or infusion treatment centres, bind to the B-cells associated with disease activity in MS and deplete them. Those treatments increase the expenses for the healthcare system and result in lifestyle burden for few patients.

Novartis said that its Kesimpta would offer the patients with flexibility of self-administering through once-monthly subcutaneous dosing, eliminating need for any premedication, or visits to an infusion centre.

The FDA approval for Kesimpta is supported by results from the Phase 3 ASCLEPIOS 1 and 2 studies, which showed that Kesimpta is superior to teriflunomide in reducing the annualised relapse rate (ARR), which is the primary endpoint.

In addition, the studies also demonstrated that the drug reduced 3-month confirmed disability progression (CDP), and the number of gadolinium-enhancing and new or enlarging lesions.

Furthermore, APLIOS, an open-label Phase 2 clinical trial that evaluated the bioequivalence of subcutaneous delivery of Kesimpta through a prefilled syringe and a Sensoready pen in RMS patients, has also showed positive results.

ASCLEPIOS I and II studies steering committee co-chair Stephen L Hauser 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 centre.”