Roivant Pill Succeeds in Reducing Dermatomyositis Symptoms!

• Roivant and its subsidiary Priovant announced on Wednesday that their inflammatory disease pill was successful in a Phase 3 trial for the rare condition dermatomyositis, significantly reducing the disorder's signs and symptoms more than a placebo over one year.

• Company executives plan to request FDA approval for the pill, named brepocitinib, in early 2026, citing trial results as “the first ever positive registrational trial for a targeted therapy” in dermatomyositis.

• Brepocitinib is being developed by Priovant Therapeutics, which is partially owned by Pfizer. The major pharmaceutical company licensed the pill to Roivant in 2022 as part of a pipeline reduction.

Brepocitinib inhibits TYK2 and JAK1, two proteins in the Janus kinase family. Drugs in this category, like Pfizer’s Xeljanz, Bristol Myers Squibb’s Sotyktu, and AbbVie’s Rinvoq, have received FDA approval for autoimmune conditions such as rheumatoid arthritis, psoriasis, and eczema.

Some also pose a risk of cardiovascular harm due to blood clots, although this hasn’t hindered sales of Rinvoq, which reached nearly $6 billion in 2024.

By outlicensing the drug to Priovant, Pfizer chose a rare disease strategy for brepocitinib, potentially facilitating FDA approval through smaller, less expensive clinical trials. Besides dermatomyositis, which causes muscle weakness and skin lesions and affects about 34,000 people in the U.S., Priovant is testing the pill for inflammatory eye and skin disorders.

In the dermatomyositis study, Priovant recruited 241 participants, assigning one-third to take 30 milligrams of brepocitinib daily, another third 15 milligrams daily, and the rest a placebo. Those on the 30 milligram dose showed significantly better results on a scale measuring biological markers, clinical signs, and activity measures compared to the placebo group after the 52-week treatment period, Roivant reported.

More participants on the 30 milligram dose reduced their steroid use to less than 2.5 milligrams daily or stopped steroid use entirely compared to the placebo group, Roivant stated.

Side effects of brepocitinib were similar to those in previous clinical trials, which included more frequent infections. However, trial investigators noted there were no cardiovascular events from blood clots.

“The success of the VALOR study marks a groundbreaking moment for the dermatomyositis field, and the results confirm brepocitinib’s potential as a significant treatment option for many dermatomyositis patients once approved,” stated Ruth Ann Vleugels, director of the autoimmune skin disease center at Brigham and Women’s Hospital, in a statement from the companies.

Roivant shares increased by 10% in trading on Wednesday.