FDA Accepts Pfizer's SNDA For Priority Review Of Rapamune

(RTTNews) - Pfizer Inc. (PFE) said Friday that the U.S. Food and Drug Administration has accepted for priority review a supplemental New Drug Application for Rapamune for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal.

With the priority review designation for the sNDA, the company expects a decision in June based on the anticipated Prescription Drug User Fee Act action date.

The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus trial. The MILES trial included 89 LAM patients with moderate lung impairment who were randomized to receive Rapamune or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with Rapamune for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.

Rapamune is indicated for the prevention of organ rejection in kidney transplant patients aged 13 years or older.