FDA Advisory Committee Backs Pending Approval of Xeljanz to Treat Psoriatic Arthritis

The FDA’s Arthritis Advisory Committee voted 10 to 1 yesterday in favor of tofacitinib citrate (Xeljanz) to treat adult patients with active psoriatic arthritis (PsA).
 
Pfizer Inc submitted a supplemental New Drug Application (sNDA) for 5 mg of tofacitinib citrate twice-daily and 11 mg once daily of Xeljanz XR extended release. The decision on whether to approve tofacitinib for PsA is expected by December 2017.
 
Tofacitinib citrate is a Janus kinase inhibitor. It is currently approved to treat patients with moderate-to-active rheumatoid arthritis who did not respond to methotrexate or other non-biologic disease-modifying antirheumatic drugs.
 
“Today marks an important positive step in our journey to potentially bring tofacitinib to adult patients living with active psoriatic arthritis and we are pleased with the Committee’s positive recommendation based on the favorable benefit/risk profile for tofacitinib,” Michael Corbo, chief developmental officer of Inflammation & Immunology at Pfizer Global Product Development, said in a press release. “If approved, tofacitinib would be the first Janus kinase inhibitor for psoriatic arthritis. We look forward to working with the FDA to complete review of the applications.”
 
The committee discussions were based on data in the sNDA from the tofacitinib phase 3 trial in PsA, and additional safety analyses form the broader tofacitinib clinical development program. 
 
 
 
 


Stay up to date on the latest news in specialty pharmacy by getting Specialty Pharmacy Times in your mailbox or inbox for free!

Click here to sign up for free for the bi-monthly Specialty Pharmacy Times print journal delivered to your address.

Click here to sign up for our email newsletters delivered every Monday, Wednesday, and Friday, in addition to breaking news alerts.

Click here to follow us on Facebook. 

Click here to follow us on Twitter. 

Click here to join our LinkedIn group. 


Related Articles

Upadacitinib (Rinvoq, AbbVie) is indicated for adults with moderate-to-severe rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
Results from an ongoing safety trial of tofacitinib demonstrated an increased risk of blood clots and death associated with a 10-mg twice daily dose of tofacitinib in patients with rheumatoid arthritis.
Top news of the day from across the health care landscape.
Company Profile >
Industry Guide >
Market News >
Peer Exchange >
Conferences >
Subscribe >
Specialty Times Resources
About Us
Advertise
Careers
Contact Us
Terms & Conditions
Privacy
MJH Associates >
Pharmacy Times
OTCGuide
American Journal of Managed Care
Cure
MD Magazine
ONCLive
Targeted Oncology
Physicians' Education Resource
Pharmacy & Healthcare Communications, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright Specialty Pharmacy Times 2006-2019
Pharmacy & Healthcare Communications, LLC. All Rights Reserved.
 

$vacMongoViewPlus$