Pfizer seeks FDA approval for Xeljanz modified release tablets to treat RA
Pfizer is seeking approval from the US Food and Drug Administration (FDA) for its Xeljanz tablets to treat moderate-to-severe rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to methotrexate (MTX).
The company has submitted NDA based on data from a clinical pharmacology programme -the NDA for Xeljanz 10mg and 5mg tablets twice-daily is currently under review with the FDA to treat adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. So far, Xeljanz received approval in 40 countries.
Xeljanz is a prescription medicine. It is a JAK inhibitor and it may be used as a single agent or in combination with MTX or other non-biologic disease-modifying anti-rheumatic drugs. The benefit:risk profile of Xeljanz in RA was studied in around 6,200 patients in the global clinical development programme for the tablet in moderate to severe RA.
Pfizer senior vice-president Dr Rory O’Connor said: “This filing underscores our commitment to helping advance patient care and our goal of providing innovative solutions for patients with RA.”