Pfizer Inc. (PFE) Seeks Approval For Rare Lung Disease Medicine
The U.S. FDA has accepted Pfizer Inc. (NYSE:PFE)’s supplemental New Drug Application for Rapamune for priority review. The review is concerning the immunosuppressant’s potential usage for a rare, fatal lung condition, Lymph-Angioleio-Myomatosis or LAM.
If approved, this Pfizer drug would be the first FDA-approved therapy for LAM and the company is expecting the FDA to announce its decision by June 2015. The company filed this application based on its results from a clinical trial involving 89 patients with this lung condition who were randomized to receive Rapamune or placebo. The patients treated with Rapamune experienced stabilization of lung function following a one year treatment.
Pfizer Inc. (NYSE:PFE) noted that the company provided the study drug and a part of funding for the LAM trial, however, it didn’t have any involvement in the design or conduct of the trial.
Lymph-Angioleio-Myomatosis is a rare, progressive lung condition, generally affecting women during their childbearing years. The condition results from abnormal growth of smooth muscle like cells. Over the period, such abnormal growth of the cells could lead to airway obstruction.
Pfizer Inc. (NYSE:PFE)’s Rapamune is currently indicated for the prevention of “organ rejection,” following kidney transplant in patients aged 13 years and above. Initially, Rapamune is administered in combination with cyclosporine and corticosteroids as its safety and efficacy without cyclosporine have not been established in newly transplanted patients.
High blood pressure, nausea, headache, pain, fever, diarrhea, anemia, urinary tract infection and low platelet count are some of the common side effects associated with Rapamune. The drug could also induce swelling in hands, feet and many tissues of body. It could also induce high cholesterol and triglyceride levels in blood. Hence, the safety indication suggests periodic blood tests during treatment to check individual lipid levels. The drug is also indicated to increase risk for viral infections.
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