Date: 2017-12-14
Type of information: Granting of a Market Authorisation in the US
Product name: Xeljanz®
Compound: tofacitinib
Therapeutic area: Autoimmune diseases - Dermatological diseases
Action mechanism:
- kinase inhibitor/Janus kinase inhibitor. Tofacitinib is an oral Janus kinase (JAK) inhibitor. This drug is already approved for the treatment of moderate to severe rheumatoid arthritis (RA) as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs).
Company: Pfizer (USA - NY)
Disease: moderate to severe chronic plaque psoriasis
Latest news:
- • On December 14, 2017, Pfizer announced that the FDA has approved Xeljanz® 5 mg twice daily (BID) and Xeljanz® XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). The approval was based on data from the Phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, which consisted of two pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance. The findings from OPAL Broaden and OPAL Beyond were published in October 2017 in the New England Journal of Medicine.
- Both pivotal studies met their two primary efficacy endpoints, demonstrating statistically significant improvements in American College of Rheumatology 20 (ACR20) response and change from baseline in the Health Assessment Questionnaire–Disability Index (HAQ-DI) score at three months in patients receiving Xeljanz® 5 mg BID treatment in combination with a nonbiologic DMARD, compared to those treated with placebo. In OPAL Broaden, 50% of patients taking Xeljanz® 5 mg BID achieved an ACR20 response, compared to 33% of patients taking placebo (p?0.05), at three months. In OPAL Beyond, 50% of patients achieved an ACR20 response with Xeljanz® 5 mg BID, compared to 24% of patients taking placebo (p?0.05), at three months. In both studies, statistically significant improvements in ACR20 response was also seen with Xeljanz® 5 mg BID compared to placebo at week 2, a secondary endpoint and the first post-baseline assessment (OPAL Broaden: 22% and 6% [p=0.0003], respectively; OPAL Beyond: 27% and 13% [p=0.0046], respectively).
- • On October 14, 2015, Pfizer announced it has received a Complete Response Letter from the FDA for its supplemental New Drug Application (sNDA) for Xeljanz® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The Agency provided recommendations specific to the moderate to severe chronic plaque psoriasis sNDA. Pfizer will work with the Agency to determine an appropriate path forward to address their comments, including providing additional safety analyses of Xeljanz® for the proposed indication.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-12-14
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
