Shorter FDA Review for Tx of Rare Lung Disorder
Pfizer announced that the Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for Rapamune (sirolimus) for the treatment of lymphangioleiomyomatosis (LAM).
The sNDA submission is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus (MILES) Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive Rapamune (dose adjusted to 5–15ng/mL) 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 (FEV1).
Rapamune is already indicated for organ rejection prophylaxis in renal transplant patients, in combination with cyclosporine and corticosteroids.
For more information visit Rapamune.com.