FDA Approves Novartis Drug To Treat More Severe Form Of Multiple Sclerosis

Culminating a month that saw mostly favorable FDA verdicts, Novartis AG NVS announced regulatory approval for its multiple sclerosis drug.

What Happened

Swiss pharma giant Novartis announced Tuesday evening the FDA greenlighted its oral drug to treat adults with relapsing forms of multiple sclerosis, including isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

Multiple sclerosis is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communications between the brain and other parts of the body.

The drug is likely to be priced at $88,000 per year, Reuters reported, citing Novartis' Head of Pharmaceuticals Paul Hudson.

Mayzent is reportedly a synthetic derivative of Novartis' best-selling relapsing multiple sclerosis drug Gilenya.

Why It's Important

Novartis said Mayzent is the first and only treatment approved for patients with active secondary progressive multiple sclerosis (SPMS) in over 15 years.

With data suggesting that up to 80 percent of patients with relapsing-remitting multiple sclerosis (RRMS), developing SPMS, Mayzent is an effective treatment for RRMS patients in transition and those with active SPMS, who have transitioned.

Novartis also said patients may not require a first dose observation unless they have certain pre-existing cardiac conditions.

What's Next

Novartis expects to make available Mayzent in the U.S. in about one week. The company also said regulatory filings for Mayzent is currently underway with authorities outside the U.S., with a decision by the European Union expected in late 2019.

The stock traded around $94.94 per share Wednesday morning.

Related Links:

The Daily Biotech Pulse: FDA Nod For Novartis, Jazz Positive Late-Stage Data For Sleep Disorder Drug, Genfit IPO

The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trials, Earnings And IPOs