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news.The US FDA has approved to review the New Drug Application (NDA) for Pfizer's tofacitinib, indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).
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Tofacitinib an investigational drug is an oral JAK inhibitor.
The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in August 2012 for the NDA.
The company has also submitted an application for this indication for tofacitinib to regulatory authorities in Japan.
An application for tofacitinib for the treatment of adult patients with moderate-to-severe active RA is being reviewed by the European Medicines Agency, as disclosed in November.
Pfizer Specialty Care and Oncology president and general manager Geno Germano said the move by the regulatory agency is a key milestone that would help in bringing tofacitinib to RA patients who are in need of additional therapeutic options.
"We are proud of the comprehensive Phase 3 clinical program that we have completed and believe that, if approved by the FDA, tofacitinib has the potential to improve the lives of people with RA," Germano added.