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news.The US Food and Drug Administration (FDA) has accepted Pfizer's supplemental New Drug Application (sNDA) for priority review of Rapamune (sirolimus) to treat Lymphangioleiomyomatosis (LAM), a progressive lung disease in women of childbearing age.
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The company estimates the FDA decision for the sNDA in June 2015 based on the anticipated Prescription Drug User Fee Act (PDUFA) action date.
Pfizer Global Innovative Pharmaceuticals Business Global Medicines Development managing director, senior vice-president and head Steve Romano said: "If approved, Rapamune would be the first FDA approved treatment option for patients living with LAM."
The sNDA is based on the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus (MILES) Trial results.
The trial has been carried out within the NIH Rare Lung Diseases Consortium.
The University Of Cincinnati School of Medicine Critical Care and Sleep Medicine pulmonary director Dr Francis McCormack: "The results of the MILES Trial demonstrated that Rapamune has the potential to stabilize lung decline in patients suffering from LAM.
"We are excited about the FDA’s review of Rapamune and the potential to make this medication available tozLAM patients."
Rapamune is indicated for the organ rejection prevention in kidney transplant patients, aged 13 years or older.