Pozen submits application for aspirin drug candidate to FDA
CHAPEL HILL - Chapel Hill-based pharmaceutical company Pozen Inc. submitted its new drug application to the U.S. Food and Drug Administration for two dosage forms of its aspirin drug candidate.
The company is looking for approval to market the tablets for the secondary prevention of cardiovascular disease in patients at-risk for aspirin-induced ulcers, according to a company news release.
The FDA submission was based on data from clinical trials that included two Phase 3 studies for PA32540 conducted under special protocol assessment agreed to with the FDA, which met their primary and secondary endpoints, as well as Phase 1 studies for both PA32540 and PA8140, the release stated.
Biogen Idec gets approval for MS pill
WESTON, Mass.- Biogen Idec, a Massachusetts-based drug company that has operations in the Research Triangle Park, announced Wednesday that it has received U.S. Food and Drug Administration approval for an oral treatment for people with relapsing forms of multiple sclerosis.
The company said the drug, Tecfidera, has been proven in clinical trials to reduce measures of disease activity including relapses and the development of brain lesions, as well slowing disability progression over time.
Mike McBrierty, a spokesman for the company, said Biogen Idec officials are assessing how capacity at an oral solid-dose facility in the Research Triangle Park can further augment its current supply chain for Tecfidera.
The oral solid-dose facility is on the RTP campus Eisai Inc., the U.S. pharmaceutical business of a Japanese company. The companies announced a manufacturing partnership last year.