U.S. panel split on Pfizer rare disease drug
(Reuters) - A U.S. health advisory panel on Thursday issued a split vote on data for Pfizer Inc's drug to treat a rare neurodegenerative disease.
The U.S. Food and Drug Administration panel voted 13 to 4 that the drug did not show that it met the main goal in a study in treating the fatal condition. However, the panel also voted 13 to 4 that the drug treated a surrogate endpoint, which may correlate with treating the underlying disease.
The panel's recommendation will be considered by the U.S. Food and Drug Administration when it takes a decision on tafamidis, a relatively minor product for the world's largest drugmaker.
FDA staff on Tuesday recommended rejecting the drug saying the data did not prove that it worked well in treating the disease.
Tafamidis, which is already approved in Europe under the name Vyndaqel, is meant to treat familial amyloid polyneuropathy, a fatal condition that affects as many as 10,000 people worldwide, including about 2,500 Americans.
Pfizer's shares closed at $22.14 on Thursday on the New York Stock Exchange.
(The headline and story has been corrected to show FDA panel voted against one aspect of the drug's efficacy, but approved another.)
(Reporting by Balaji Sridharan in Bangalore; Editing by Viraj Nair)
- Washington, DC city council raises minimum wage to $11.50/hr in 2016
- Winning ticket sold in California for Mega Millions lottery: official
- UPDATE 5-Mega Millions lottery winning tickets sold in California, Georgia -Officials
- India removes barriers to U.S. embassy as anger grows over diplomat's arrest
- U.N. told up to 500 killed in South Sudan clashes: diplomats
During Soviet times, Sochi gained a reputation for tolerance but the city's once vibrant gay scene has been shrinking as Russia prepares to host the 2014 Winter Games. Slideshow