U.S. drugmaker Pfizer Inc said on Thursday the U.S. Food and Drug Administration (FDA) approved two doses of its drug Xeljanz for treatment of a joint disease.
Xeljanz was approved as a 5-mg dose taken twice daily and as an extended-release 11-mg dose taken once daily as a drug for patients with active psoriatic arthritis who have not responded to other treatments.
Psoriatic arthritis, a form of arthritis that affects some people who have skin disease psoriasis, is characterized by symptoms such as joint pain, stiffness, and swelling.
Xeljanz, which earned Pfizer $348 million in the latest quarter, was first approved in 2012 as an oral alternative to injected biotech medicines for moderate to severe rheumatoid arthritis.
The drug’s expanded label comes with the same boxed warning, cautioning against the risk of serious infections and malignancy, that accompanied its first approval.
Earlier this week, the FDA determined additional review time was necessary for Pfizer’s application to market Xeljanz as a treatment for ulcerative colitis, a bowel disease.
In 2015, the FDA rejected it as a treatment for a scaly skin condition called plaque psoriasis.
On Wednesday, Pfizer said it secured an FDA nod for its second biosimilar version of Johnson & Johnson’s rheumatoid arthritis drug Remicade.
(Reporting by Tamara Mathias in Bengaluru; Editing by Sandra Maler and David Gregorio)