Law360, New York (May 09, 2012, 5:12 PM ET) -- Despite safety concerns, a U.S. Food and Drug Administration advisory panel voted 8-2 Wednesday to recommend approval of Pfizer Inc.'s new rheumatoid arthritis drug for patients who don't adequately respond to other treatments.
The two members of the FDA's Arthritis Advisory Committee who voted against approval of tofacitinib both said they supported the drug, but not for such a broad class of patients. Members of the panel also expressed concerns about safety data that showed increased incidences of lymphoma and serious infections.
“With the data I...
FDA Advisory Panel Backs Pfizer Arthritis Drug
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