This article is more than 5 years old. Information may no longer be current.
FDA committee supports approval of Xeljanz for UC
The FDA Gastrointestinal Drugs Advisory Committee voted yesterday in support of Pfizer’s supplemental new drug application for Xeljanz for moderate-to-severe ulcerative colitis in adults.
“If approved, [Xeljanz, tofacitinib] will be the first Janus kinase inhibitor and the first oral therapy for adults living with moderately to severely active ulcerative colitis. We look forward to working with the FDA as it completes the review of our pending application,” Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, said in a press release from the company.
Pfizer’s sNDA proposed an 8-week induction regimen of 10 mg twice daily tofacitinib, with the option to extend induction by 8 additional weeks, followed by a 5-mg twice daily maintenance dose, with the option of a 10-mg twice daily dose for maintenance in patients with inadequate response, loss of response, or intolerance to anti-TNFs.
The committee voted 15-0 in support of extending the use of 10 mg tofacitinib twice daily from 8 to 16 weeks of induction in adults who have not achieved adequate response by week 8. The committee also voted unanimously in support of the 10 mg twice-daily dose as maintenance therapy for patients with inadequate response, loss of response or intolerance to anti-TNF therapy, according to the press release.
Additionally, the committee voted 8-7 against initiating a post-marketing efficacy study comparing a 10-mg twice daily continuous dosing regimen vs. a 10-mg twice daily induction and 5-mg twice daily maintenance regimen.
The FDA’s approval decision for tofacitinib for UC is expected by the Prescription Drug User Fee Act (PDUFA) date in June 2018.
Tofacitinib is currently approved for adults with rheumatoid arthritis and psoriatic arthritis.
Disclosures: Corbo is employed by Pfizer.