FDA Okays Lung Drug


The US Food and Drug Administration approved a new use for sirolimus, treating a rare lung disease.

The FDA today approved sirolimus (Rapamune/Wyeth) to treat an extremely rare lung disease called lymphangioleiomyomatosis.

The approval was based on a 2-year study of patients with the disease, compared to a group getting a placebo.

The research showed that patients on the drug had a slower loss of lung function.

“After discontinuation of Rapamune, the decline in lung function resumed at a rate similar to the placebo group,” the FDA said in a news release.

It is available in both tablet form and as an oral solution. Side effects include mouth and lip ulcers, diarrhea, abdominal pain, nausea, sore throat, acne, chest pain, and leg swelling.

Sirolimus has been used since 1999 as an immunosuppressive drug for kidney transplant patients.

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