Tuesday, December 1, 2020
Home Latest Pharma-News PFIZER ANNOUNCES PHASE 3 STUDY RESULTS FOR XELJANZ ® IN ANKYLOSING...

PFIZER ANNOUNCES PHASE 3 STUDY RESULTS FOR XELJANZ ® IN ANKYLOSING SPONDYLITIS

November 06, 2020: Pfizer announced positive results from a Phase 3 investigational study evaluating the safety and efficacy of tofacitinib in adults with active ankylosing spondylitis (AS). Tofacitinib is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of AS.

The study met its primary and key secondary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 20 and 40 response, respectively, compared to placebo at week 16.

- Advertisement -

The data will be presented for the first time during a late-breaking virtual oral presentation on Monday, November 9 at 12:45 p.m. ET during ACR Convergence, the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting (November 5-9).

The AS study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that included 270 adult patients with active AS. The study evaluated the efficacy and safety of tofacitinib 5 mg twice daily versus placebo.

The study met its primary endpoint showing that at week 16, the percentage of patients achieving an ASAS20 response was significantly greater with tofacitinib (56.4%) versus placebo (29.4%) (p<0.0001).

In addition, the percentage of ASAS40 response was significantly greater with tofacitinib (40.6%) versus placebo (12.5%) (p<0.0001), a key secondary endpoint of the study.

ASAS20/40 are used for defining improvement or response to treatment.

The most common adverse events in this study, occurring in greater than five percent of any treatment group, were upper respiratory tract infection, nasopharyngitis, diarrhea, alanine aminotransferase (ALT) increased, arthralgia and headache.1b

“Ankylosing spondylitis is a debilitating condition, and its often progressive nature affects patients for most of their adult lives, limiting physical function and perceived health-related quality of life,”  said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.

“We are proud to share these positive results from our Phase 3 investigational study for tofacitinib in adults with ankylosing spondylitis, and we believe they demonstrate Pfizer’s commitment to addressing unmet needs for those living with inflammatory conditions.”

The FDA has accepted Pfizer’s application for the AS indication and the Prescription Drug User Fee Act (PDUFA) goal date is in Q2 2021.

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-phase-3-study-results-xeljanz-r

LEAVE A REPLY

Please enter your comment!
Please enter your name here

six − 2 =

Most Popular

Eisai and Wren Therapeutics Enter Into Research Collaboration Agreement for Drug Discovery for Synucleinopathies

November 30, 2020: Eisai and Wren Therapeutics announced that the companies have entered into an exclusive research collaboration agreement aiming to advance...

AstraZeneca agreed to sell rights to Crestor to be divested to Grünenthal in Europe

December 01, 2020: AstraZeneca has agreed to sell the rights to Crestor (rosuvastatin) and associated medicines in over 30 countries in Europe, except the...

AstraZeneca’sForxiga approved in Japan for chronic heart failure

November 30, 2020: AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic heart failure (HF) who are receiving...

Moderna Announces the EC Approval for Initial 80 Million Doses of mRNA Vaccine Against COVID-19

November 25, 2020: "Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines...