RAPAMUNE® from Pfizer is the first FDA-Approved Treatment for LAM, A Rare Progressive Lung Disease

WASHINGTON - May 29, 2015 - PRLog -- The U.S. Food and Drug Administration (FDA) has approved Pfizer’s RAPAMUNE® (sirolimus) making it the first approved therapy to treat lymphangioleiomyomatosis (LAM), a rare disease that affects the lungs, kidneys and the lymphatic system, which tends to affect women of childbearing age.

The FDA approval comes from the Multicenter International Lymphangioleiomyomatosis Efficacy of Sirolimus or MILES Trial conducted by Dr. Francis X. McCormack, director of Pulmonary, Critical Care and Sleep Medicine at the University Of Cincinnati College Of Medicine and conducted within the National Institutes of Health Rare Lung Diseases Consortium. 89 LAM patients were treated with RAPAMUNE for a year and results revealed lung function stabilization by forced expiratory volume in one second (FEV1).

The approved use of RAPAMUNE is an instrumental breakthrough for LAM patients, as approximately 800 patients in the U.S. are currently diagnosed with this debilitating condition which is often fatal.

“Pfizer is proud to gain approval for RAPAMUNE as the first treatment for patients with LAM, through our work with the FDA, the clinical investigation team and the LAM Foundation,” said Rory O’Connor, MD, senior vice president and head of Global Medical Affairs, Global Innovative Pharmaceuticals Business, Pfizer Inc. “This type of cooperative effort creates opportunities for innovation in developing therapies for patients with rare diseases.”

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