US FDA approves Roivant-Priovant's skin and muscle disease drug
ROIV•Trial results and disease background
The companies said the drug improved both skin and muscle symptoms in a late-stage trial, reducing or stopping the need for steroids, which are commonly used but can cause long-term side effects.
According to the National Institutes of Health, dermatomyositis affects fewer than 5,000 people in the U.S.
FDA approves first oral drug for dermatomyositis
The U.S. Food and Drug Administration said on Thursday it approved a treatment from Roivant and partner Priovant Therapeutics for a rare disease, making it the first oral drug for the condition affecting skin and muscles.
Shares of Roivant were up nearly 3% at $37.69 in afternoon trading.
Branded as Lisraya, the drug was approved for dermatomyositis, a condition that causes painful skin rashes and progressive muscle weakness and, if untreated, can severely reduce quality of life.
