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Pfizer Inc. (NYSE FE), New York, N.Y.Product: Tofacitinib (CP-690,550) (formerly tasocitinib) Business: Autoimmune Molecular target: Janus kinase-3 (JAK-3); Janus kinase-1 (JAK-1) Description: Oral pan-Janus kinase (JAK) inhibitor An NDA for tofacitinib to treat rheumatoid arthritis (RA) is under FDA review with an Aug. 21 PDUFA date, while an MAA is under review in the EU. The product is also under review in Japan. In a conference call to discuss its 2Q12 earnings, Pfizer said FDA requested additional analysis of data in the NDA for tofacitinib, which the pharma said could cause the agency to extend its review of the product past its PDUFA date. Specifics about the request were not disclosed (see BioCentury, Aug. 6). Tofacitinib also is in Phase III testing to treat moderate to severe plaque psoriasis. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502, Osaka, Japan) has rights from Pfizer to co-market tofacitinib in Japan for RA and other undisclosed indications |
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