March 27, 2019 / 12:24 AM / 2 months ago

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

(fixes typing mistake in last graf)

March 26 (Reuters) - Novartis AG won U.S. Food and Drug Administration approval on Tuesday 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.

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. (Reporting by John Miller in Zurich and John Benny in Bengaluru; Editing by Sandra Maler)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below