Xeljanz Archives - Medical Design Sourcing

The FDA has announced that it has approved Lilly’s Olumiant (baricitinib) oral tablets to treat adults with severe alopecia areata, a form of baldness resulting from the body attacking its hair follicles.

Manifesting as patchy baldness, alopecia areata affects more than 300,000 people in the U.S.

The incidence of alopecia areata is growing.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Dr. Kendall Marcus, director of the division of dermatology and dentistry in the FDA’s Center for Drug Evaluation and Research, in a news release. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

FDA first approved Olumiant in 2018 for rheumatoid arthritis. In 2022, the drug won an indication for COVID-19 in some hospitalized COVID-19 patients.

Pfizer (NYSE:PFE) has received FDA approval for the supplemental New Drug Application (sNDA) for Xeljanz/Xeljanz XR (tofacitinib) as a treatment of adults with active ankylosing spondylitis (AS).

About 350,000 Americans have the condition.

The Xeljanz approval covers patients who had an insufficient response or intolerance to one or more tumor necrosis factor (TNF) blockers.

Xeljanz is a Janus kinase (JAK) inhibitor and the first to find approval for five indications in the U.S., noted Mike Gladstone, global president, inflammation and immunology, Pfizer, in a press release.

To win approval, Pfizer submitted data from a Phase 3, multicenter, randomized, double-blind, placebo-controlled study.

With this approval, physicians and patients now have an additional oral treatment option that can help address this chronic and often progressive disease,” said Steven Taylor, executive vice president, mission and strategic initiatives of the Arthriti…

Xeljanz

FDA approves Olumiant as first systemic therapy for baldness form

FDA approves Pfizer’s tofacitinib for ankylosing spondylitis