Regulators Accept Merck Drug For Expedited Review
From Associated Press (January 6, 2011)
WHITEHOUSE STATION, N.J. -- Drug developer Merck & Co. said Thursday U.S. and European regulators accepted its potential hepatitis C treatment boceprevir for expedited review.
The U.S. Food and Drug Administration gave the drug application priority review status and will aim to complete its review in six months, the Whitehouse Station, N.J. company said. That designation is given to drugs that offer major advances or could provide a treatment where no adequate therapy exists.
The European Medicines Agency accepted the drug application for accelerated assessment, which also is given to products that could address unmet medical needs or represent a significant improvement over current treatment options within a major health interest.
Hepatitis C is an infectious disease that can cause liver damage.
Merck acquired the drug when it merged with Schering-Plough and said last summer boceprevir met key goals in late-stage studies. The company said the drug prompted immune system responses to fighting the disease in studies involving newly treated patients and patients taking additional treatments.
Posted: January 2011