FDA approves Kesimpta for multiple sclerosis
The FDA has approved Kesimpta, the first self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis, the manufacturer announced.
Krishnan Ramanathan, PhD, senior global program director of neuroscience at Novartis, told Healio Primary Care, that Kesimpta (ofatumumab, Novartis) “changes the scope” of MS treatment.
“Kesimpta demonstrated a sound efficacy profile and allowed patients with MS to have one relapse every 10 years,” he said. “Other MS treatments have a very prolonged effect that may significantly impair the immune system for long periods of time and must be received via an escalation approach. Ofatumumab’s dose is consistent and can be taken at home.”
Novartis said in a press release that ofatumumab’s approval was based on trial data that showed, compared with Aubagio (teriunomide, Sano Genzyme), ofatumumab was associated with lower annualized relapse rates, fewer instances of worsening disability at 3 and 6 months, improved disability at 6 months, fewer lesions and lower serum neurolament light chain levels. There were also fewer injection-related reactions and serious infections among study participants who received ofatumumab.
A Novartis spokesperson told Healio Primary Care that ofatumumab’s wholesale acquisition cost is $83,000. According to the press release, ofatumumab should be available to U.S. patients in September. Regulatory filings in other countries are under way.