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FDA Accepted Review Of New Drug Application For Pfizer's (PFE) Tofacitinib

December 20, 2011 8:04 AM EST
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for tofacitinib (development code CP-690,550), an investigational novel, oral JAK inhibitor being studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in August 2012 for the NDA. Pfizer has also submitted an application for this indication for tofacitinib to regulatory authorities in Japan.

As disclosed in November, an application for tofacitinib for the treatment of adult patients with moderate-to-severe active RA is being reviewed by the European Medicines Agency.

“Pfizer is pleased to have achieved this regulatory milestone, which reflects our commitment to advancing treatments for inflammatory conditions, and constitutes a significant step toward bringing tofacitinib to RA patients who are in need of additional therapeutic options,” said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer Inc. “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.”

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Xeljanz (tofacitinib) has been approved
TonyDewitt on 2012-11-08 12:56:30
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Xeljanz (tofacitinib) has been approved on November 7th, 2012 - the hidden surprise is that it is effective against two disorders caused by HTLV: HAM and ATL. Since there are WAY more HTLV sufferers than arthritis sufferers, this drug will sell well because HTLV sufferers have no treatment for their suffering thus far.

TonyDewitt on 2012-08-17 15:01:00
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The hidden surprise in tofacitinib is that since it is a JAK inhibitor, it is effective against two disorders caused by HTLV: HAM and ATL. Once the drug is approved, 25 million HTLV sufferers will ask their doctors for tofacitinib, in order to treat HAM (which leads to being in a wheelchair) and ATL (which leads to death by a rapidly fatal leukemia). Other JAK inhibitors include AG490.

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