FDA To Review New Xeljanz Formulation For Rheumatoid Arthritis
FDA withdraws warning letter after resolution
Pfizer announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Xeljanz (tofacitinib citrate) 11mg once daily modified release tablets for the treatment of moderate to severe rheumatoid arthritis in patients with inadequate response or intolerance to methotrexate.
The NDA submission is based on data from the clinical pharmacology program designed to demonstrate equivalence in key pharmacokinetic parameters to Xeljanz 5mg twice daily. Currently the FDA is reviewing a supplemental NDA (sNDA) for Xeljanz 10mg and 5mg tablets twice daily for the treatment of moderate to severe chronlic plaque psoriasis for candidates for systemic therapy or photo therapy.
Xeljanz, a Janus kinase (JAK) inhibitor is already indicated to treat adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate (MTX). It may be used as monotherapy or in combination with MTX or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).