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Date: 2017-12-12

Type of information: Submission of a Market Application in the US

Product name: Xeljanz®

Compound: tofacitinib

Therapeutic area: Autoimmune diseases - Gastrointestinal diseases - Inflammatory diseases

Action mechanism:

  • kinase inhibitor/Janus kinase inhibitor. Tofacitinib is an oral selective Janus kinase (JAK) inhibitor. Tofacitinib preferentially inhibits JAK1 and JAK3 leading to an attenuation of signalling of interleukins (IL-2, -4, -6, -7, -9, -15, -21) and type I and type II interferons, which will result in modulation of the immune and inflammatory response.

Company: Pfizer (USA - NY)

Disease:

Latest news:

  • • On December 12, 2017, Pfizer announced that the FDA has extended the action date by three months for the supplemental New Drug Application (sNDA) for Xeljanz® (tofacitinib), an oral treatment under investigation for adult patients with moderately to severely active ulcerative colitis. The FDA determined that additional review time was necessary due to information recently submitted by Pfizer and as such constitutes a major amendment. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) date in June 2018.
  • • On July 13, 2017, Pfizer Inc. announced that the supplemental New Drug Application (sNDA) for Xeljanz® (tofacitinib citrate) for the treatment of adult patients with moderately to severely active ulcerative colitis, has been accepted for filing by the FDA. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in March 2018 for the sNDA.
  • The sNDA submission package included data from three pivotal Phase 3 studies from the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis global clinical development program (OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain) evaluating the safety and efficacy of tofacitinib in patients with moderately to severely active ulcerative colitis, and OCTAVE Open, the open label long-term extension study of tofacitinib in patients who completed or who had treatment failure in OCTAVE Sustain, or who were non-responders in OCTAVE Induction 1 or 2. Full results from OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain were published in The New England Journal of Medicine in May 2017.

Patents:

Submission of marketing authorization application USA : 2017-07-13

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes