Pfizer's Vyndaqel approved in EU

Pfizer said Thursday that European regulators approved Vyndaqel (tafamidis) as a treatment for transthyretin familial amyloid polyneuropathy (TTR-FAP) in adult patients with stage 1 symptomatic polyneuropathy. The company noted that Vyndaqel, which is expected to be available in European markets by early 2012, is the first drug approved in the EU to delay peripheral neurologic impairment in this patient population.

The decision on the oral compound was based on results from the Fx-005 trial and the Fx-006 extension study in patients with TTR-FAP. In the trials, Vyndaqel showed efficacy in delaying peripheral neurologic impairment. Further, data showed between 51 percent and 81 percent less deterioration in neurologic function, large fiber function and small fiber function among patients given Pfizer's drug compared to placebo.

The drugmaker filed for FDA approval of Vyndaqel earlier this year, but in April, the agency indicated that the application was incomplete. At the time, Pfizer indicated that it was working with the regulator to resubmit the filing.

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