Rapamune was originally approved in 1999 as an immunosuppressant
In what is being lauded as one of the fastest decisions by the regulatory body, the USFDA has approved Pfizer's a rare, progressive lung disease drug. Rapamune or Sirolimus, as it is chemically known, heads the product pipeline for Pfizer. It treats lymphangioleiomyomatosis (LAM), a deadly disease that causes damage to the lungs and affects only two to five women of childbearing age in the entire population.
Rapamune is the first drug to be approved for this disease. The drug underwent safety and efficacy tests in a clinical trial on 89 patients over a 24 month period. A 12 month treatment period followed by an observation period of the same length.
The drug was approved originally approved in 1999 as an immunosuppressive agent. As it was found to offer better treatment results over others, it was designated a breakthrough therapy. It also received an orphan drug designation because of the rarity of LAM.
