NEW YORK: The U.S. Food and Drug Administration on Monday approved Pfizer Inc's oral drug, tafamidis, to treat a rare and fatal heart disease called transthyretin amyloid cardiomyopathy, the U.S drugmaker said.
"There were three factors we took into consideration on this price: the transformative nature of this compound, the population ... and the third would be our capacity to ramp up diagnosis over time," Paul Levesque, head of rare disease at Pfizer, said in a phone interview. The drug, which received FDA breakthrough status in May, reduced the risk of death for patients with the disease by 30 percent when compared with placebo in clinical trials.
As the disease primarily affects an older population, a significant percentage of U.S. patients will likely be on the government's Medicare program.