(This Aug 27 story has been republished, with no changes to text.)
By Christy Santhosh
Aug 27 (Reuters) – 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 closed up 2% at $37.58 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.
“This moment represents a litany of firsts for dermatomyositis patients,” Priovant CEO Ben Zimmer told Reuters, calling it the first oral treatment and the first to target immune pathways linked to the disease, with skin, muscle, physical function and steroid-sparing benefits.
Zimmer said the company will reveal pricing details for the drug through an investor call on Friday.
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.
In the trial, patients receiving a daily 30 mg dose of brepocitinib (Lisraya) achieved a mean total improvement score of 46.5 after 52 weeks, compared with 31.2 for placebo. The difference was statistically significant, with benefits seen as early as week four, the companies said.
“While dermatomyositis remains a relatively under-appreciated indication within inflammation and immunology, we view it as a highly attractive commercial opportunity for Roivant.” said J.P.Morgan analyst Brian Cheng.
Cheng forecasts U.S. peak annual sales of more than $2 billion for Lisraya in dermatomyositis alone by the early 2030s.
Pfizer in 2021 licensed brepocitinib to Priovant Therapeutics, a joint company it created with Roivant.
Octapharma’s intravenous drug Octagam 10% is the only other modern, targeted therapy that is FDA-approved for the condition.
According to the National Institutes of Health, dermatomyositis affects fewer than 5,000 people in the U.S.
(Reporting by Christy Santhosh in Bengaluru; Editing by Vijay Kishore)
