MS drugs market heats up as FDA supports new Novartis pill

The FDA has approved the Novartis Mayzent Multiple Sclerosis (siponimod) pill against recurrent forms of the disease, thus bumping into a much delayed Celgene rival.

Mayzent's approval comes shortly after Celgene's late filing for his drug ozanimod MS, which should have been reviewed by the FDA if it was not.

The FDA has approved Mayzent (siponimod) for adults with recurrent forms of the disease, including secondary progressive multiple sclerosis (MSPS), active disease, relapsing remitting multiple sclerosis (MS) with active disease, and relapsing remitting multiple sclerosis (MS) and being clinically isolated. syndrome (CIS).

SPMS is a debilitating form of multiple sclerosis characterized by a progressive and irreversible neurological handicap. Mayzent should be available in the United States in about a week.

At $ 88,000 a year, Mayzent is the first oral medication to treat secondary progressive MS. It also poses a threat to Roche's new flagship drug, Ocrevus (ocrelizumab), an injection that also covers recurrent relapsing disease, including SPMS.

Novartis also targets Biogen and its Tecfidera (Dimethyl Fumarate), which has generated significant sales in recent years, but may have unpleasant gastrointestinal side effects.

Most patients progressively move from RRMS to SPMS. Therefore, it is essential that patients begin their treatment early to help slow the progression of the disability.

The progression of disability usually includes, but is not limited to, an impact on ambulation, which could lead patients to need a walking aid or to help them to walk. wheelchair, bladder dysfunction and cognitive decline.

Mayzent significantly reduces the risk of progression of disability, measured after three months, by 21% compared to placebo in a group of patients with MSPS who have been living with the disease for about 16 years.

Patients will not need any initial cardiac monitoring unless they already have heart disease.

Novartis has also filed Mayzent with European regulators and is awaiting a decision by the end of 2019.

The Swiss company is expecting further regulatory decisions in Switzerland, Japan, Australia and Canada this year.