Pfizer Gets OK On Drug For Rare Lung Disorder

Pfizer Inc. PFE obtained regulatory approval Thursday to use its Rapamune drug as a treatment for a rare and often fatal lung disorder affecting mostly women.

The disease, which affects between two and five women per million worldwide, is called lymphangioleiomyomatosis, or LAM.

"We are thrilled about the possibility of getting a therapy approved to treat this rare and potentially deadly disease," Susan E. Sherman, director of the LAM Foundation said when Pfizer's application was filed in February.

Rapamune has been approved since 1999 for preventing organ rejection in kidney transplant patients, and had U.S. sales of about $206 million in the 12 months ended August 2014.

But Dr. Reddy's Laboratories Ltd (ADR) RDY launched a generic equivalent in October, and Pfizer's Rapamune sales fell 39 percent to $53 million in the recent first quarter.

About a year ago, Pfizer agreed to pay $35 million to settle U.S. Department of Justice claims that its Wyeth unit illegally marketed the drug Rapamune, and encouraged doctors and hospitals to prescribe it for off-label uses.

Regulators claimed the improper promotion predated Pfizer's 2009 acquisition of Wyeth, according to Reuters.

Pfizer closed up $0.14 Thursday at $34.44.

Posted In: NewsFDARapamune
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