Swiss pharmaceutical giant Novartis International AG (NYSE: NVS) on Friday said its ofatumumab met the primary and secondary endpoints of Phase 3 clinical trials for the treatment of multiple sclerosis.
The trials demonstrated the therapy’s efficacy in reducing the
number of confirmed relapses as well as delaying disability progression.
The drug, which has already received approval for the treatment of chronic lymphocytic leukemia, could boost overall sales once approved for multiple sclerosis also.
The company said it would initiate submissions to health
authorities by the end of this year.
“Ofatumumab, if approved, could be a highly attractive treatment option for a broad RMS patient population, including early MS,” said John Tsai, Head Global Drug Development and Chief Medical Officer, Novartis. “The powerful study results are a reflection of our commitment to reimagine MS treatment at all stages of the disease.”
Earlier this year, Novartis had won an FDA approval for Mayzent, a drug used for patients suffering from active secondary progressive multiple sclerosis.
Novartis shares gained 1.6% during pre-market trading on Friday. The stock has jumped 22% since the beginning of this year.
New threat to Sanofi, Roche
The latest development is set to pit Novartis directly against Sanofi SA (NASDAQ: SNY) and Roche in the multiple sclerosis realm. Novartis said the clinical trials showed that its drug had superior efficacy when compared with Sanofi’s treatment teriflunomide (Aubagio).
However, teriflunomide is a smaller player in terms of sales, and Novartis’ primary competition would be with Roche’s blockbuster drug ocrevus. Notably, ocrevus is the solo approved therapy for the treatment of primary progressive multiple sclerosis.
SNY shares were trading down 0.12% during pre-market trading