Novartis gets U.S. approval for new drug to treat multiple sclerosis

[March 27, 2019]  (Reuters) - Novartis AG won U.S. Food and Drug Administration approval for its new multiple sclerosis drug Mayzent, as the Swiss drugmaker seeks to tap a new group of patients in whom the neurological disease has shifted from intermittent attacks to a gradually worsening progression.

Novartis will price the drug at $88,000 per year, its head of pharmaceuticals Paul Hudson told Reuters.

The drug was approved for use in adults with relapsing forms of the disease, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Mayzent is a synthetic derivative of Gilenya that has a similar way of working but which Novartis has modified to try to reduce side effects like a slow heart rate.

Novartis' older Gilenya MS drug is currently the company's biggest seller at more than $3.34 billion annually for the most-common form of the disease, relapsing MS, that is characterized by spells of stability interrupted by attacks in which patients' conditions get worse.

With Mayzent's new formula, Novartis is targeting largely older MS patients who have transitioned from relapsing disease to a new, emerging MS state where their conditions gradually deteriorate.

The cost could prove a stumbling block according to the independent Boston-based group Institute for Clinical and Economic Review (ICER).

Pricing it near the level of another recent MS drug entry, Roche's Ocrevus that lists at about $65,000 annually, would put the Novartis medicine "well above commonly cited thresholds for cost effectiveness", ICER said in a draft report.

Mayzent revenue is estimated to reach about $800 million by 2022, according to the median estimate of six analysts surveyed by Refinitiv.

Stefan Schneider, an analyst at Bank Vontobel, said Mayzent's approval was only for patients with the active type of secondary progressive of multiple sclerosis, where their condition steadily deteriorates after a few years of worsening function followed by recovery periods.

Patients with this condition represented only 40 percent of the potential market opportunity, he said, while other MS drugs could be used to treat the phase where they have periods of recovery.

(Reporting by John Miller and John Revill in Zurich and John Benny in Bengaluru; Editing by Sandra Maler/Keith Weir)

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