FDA Greenlights Novartis’ Kesimpta for Multiple Sclerosis
The U.S. Food and Drug Administration (FDA) approved Novartis’ Kesimpta (ofatumumab) for relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. The drug is the first B-cell therapy that can be self-administered using the company’s Sensoready autoinjector pen. It is a once-a-month therapy.
Typically, B-cell treatments are only available in hospitals or infusion centers. The drug was originally approved by the FDA in 2009 for chronic lymphocytic leukemia (CLL) as an intravenous infusion and is marketed for that indication under the name Arzerra. It was then studied in a new development program in RMS because B-cells play a critical role in the development of autoimmune diseases like MS. The RMS program took 10 years and studied more than 2,300 patients globally.
“Multiple sclerosis (MS) 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.”
The drug will have a list price of $83,000, which a company spokesperson told FiercePharma, makes it “one of the lowest-cost branded (disease-modifying therapies),” which “is priced competitively to reflect its unique value and to ensure broad access.”
It will join plenty of competitors, including Sanofi and Genzyme’s Aubagio and Roche’s Ocrevus. Others in the field that are part of a type of therapy known as S1P modulators include Bristol Myers Squibb’s Zeposia, and Novartis’ own Mayzent and Gilenya.
“Despite this being a crowded space, we believe that there’s still a significant unmet need,” Victor Bulto, Novartis’ U.S. pharma president, told Fierce.
Kesimpta’s approval was built on data from the Phase III ASCLEPIOS I and II trials. In them, Kesimpta demonstrated superiority to Sanofi and Genzyme’s Aubagio (teriflunomide) in significantly reducing the annualized relapse rate and the number of gadolinium-enhancing (GD+) T1 and new or enlarging T2 lesions.
ASCLEPIOS I and II were identical studies that evaluated the safety and efficacy of the 20-mg dose of Kesimpta via monthly subcutaneous injections compared to oral Aubagio 14-mg tablets taken once a day in adults with RMS. The trials enrolled 1,882 patients with MS between the ages of 18 and 55 years and with an Expanded Disability Status Scale (EDSS) score between 0 and 5.5. The trials were conducted in more than 350 locations in 37 countries.
The drug is expected to hit the market in the U.S. in early September. Regulatory filings are underway globally, with approval in Europe expected in the second quarter of next year.
“At Novartis, we challenge treatment paradigms and strive to offer the best treatment choice for patients,” said Marie-France Tschudin, president, Novartis Pharmaceuticals. “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.”