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FDA Declines to Expand Tofacitinib Label to Include Plaque Psoriasis

Agency asks for more safety data

The FDA has declined to approve the oral rheumatoid arthritis (RA) drug tofacitinib citrate (Xeljanz, Pfizer) for the treatment of moderate-to-severe plaque psoriasis in adults. Pfizer announced that it has been asked to provide additional safety analyses of tofacitinib for the proposed indication.

Psoriasis affects 7.4 million people in the U.S. The most common form is plaque psoriasis, which affects about 80% percent of people who have the condition.2a Of those, as many as 20% have moderate-to-severe chronic plaque psoriasis.2b

Tofacitinib citrate is the only Janus kinase (JAK) inhibitor approved for the treatment of moderate to severe rheumatoid arthritis (RA) as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs). The clinical profile of tofacitinib in RA was studied in approximately 6,200 patients with approximately 16,800 patient-years of drug exposure in the global clinical development program in moderate-to-severe RA.

Sources: Pfizer; October 14, 2015; and Reuters; October 14, 2015.

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