Pfizer is seeking approval from the US Food and Drug Administration (FDA) for its Xeljanz (tofacitinib citrate) 11mg once-daily modified release tablets to treat moderate-to-severe rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to methotrexate (MTX).
FDA has accepted the firm’s new drug application (NDA) for review of the once daily formulation of Xeljanz modified release tablets.
Xeljanz is a prescription medicine known as Janus kinase (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 (DMARDs).
Pfizer global medical affairs, global innovative pharmaceuticals business head and 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."
The company has submitted NDA based on data from a clinical pharmacology programme that is designed to show equivalence in key pharmacokinetic parameters to Xeljanz 5mg twice-daily.
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.
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.
Xeljanz received approval in 40 countries to treat moderate to severe RA, while in the US, it has a boxed warning for serious infections and malignancies.
Image: X-ray of a hand with rheumatoid arthritis. Photo: courtesy of Bernd Brägelmann.