Novartis is not planning to open a clinical trial of Kesimpta (ofatumumab) as a potential treatment for primary progressive multiple sclerosis (PPMS) anytime soon, a company executive said. But it is well aware of the “unmet need” for therapy options among this patient group, and is exploring avenues.
“We do recognize there is unmet need with PPMS patients, who make up close to 10% of the MS patient population,” Dharmesh Patel, MD, vice president, medical unit head of neuroscience at Novartis, said in an interview with MS News Today in August, shortly after Kesimpta’s U.S. approval.
“The life-cycle management plans for Kesimpta are still evolving,” Patel added. “We have a strong and long history of bringing new medications for patients with neurological diseases for the last 75 years. We are always evaluating the current unmet needs … and looking at safety and Kesimpta’s place in a future portfolio.”
He urged patients to “stay tuned,” side-stepping questions directly addressing PPMS and Kesimpta — an anti-CD20 monoclonal antibody treatment targeting select B-cells, and as such one with similarities to Ocrevus (ocrelizumab, by Genentech), the only disease-modifying therapy for PPMS approved in the U.S. and Europe.
“We have a pipeline, but some of this information is not yet in the public domain,” Patel said. “We are evaluating other options [to Kesimpta] as well, including those targeting PPMS patients.”
Kesimpta is believed to work by destroying B-cells, immune system cells that drive inflammation in MS. It is indicated for people with all forms of relapsing multiple sclerosis (MS): clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
Ocrevus is also approved for relapsing MS, with its clinical trials having shown effectiveness in both primary progressive and relapsing patients.
More research is needed in progressive disease, said Gabriel Pardo, MD, director of the Oklahoma Medical Research Foundation Multiple Sclerosis Center of Excellence who took part in Kesimpta’s pivotal trials.
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