The U.S. Food and Drug Administration on Monday approved Pfizer Inc's oral ...
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 company has been in talks with insurers and is confident the drug will be reimbursed at the $225,000 price, he said.
Vyndaqel currently sells for about $100,000 a year outside the United States as a treatment for FAP. It was approved in Japan for transthyretin amyloid cardiomyopathy in May at a price of around $750,000 a year that was set by a government body, Pfizer said. Pfizer believes there could be 400,000 to 500,000 patients in developed markets around the world and said the current rate of those diagnosed may be as low as 0.5 percent to 1 percent.
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