(Reuters) – The U.S. Food and Drug Administration said on Friday it approved Ariad Pharmaceuticals Inc‘s drug to treat two rare types of blood cancer, three months ahead of the review date.
Iclusig was approved to treat chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia.
The drug, generically known as ponatinib, is being granted an orphan product status, intended for drugs that aim to treat rare diseases.
The FDA said that Iclusig was approved under its accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies.
Orphan drug designation is granted by the health regulator to drugs or biologics that treat a condition affecting less than 200,000 Americans.
The status grants the drugmaker a marketing exclusivity of seven years in the United States, upon approval.
Iclusig, which blocks certain proteins that stimulate the development of cancer cells, was to be reviewed by the FDA on March 27. (http://link.reuters.com/vut64t)
(Reporting By Vrinda Manocha in Bangalore; Editing by Maju Samuel)
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FDA OKs Ariad’s drug for two rare blood cancers
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FDA OKs Ariad’s drug for two rare blood cancers
