Merck MRK, known as MSD outside the United States and Canada, announced
today that the U.S. Food and Drug Administration (FDA) has granted
MK-5172/MK-8742 Breakthrough Therapy designation for treatment of chronic
hepatitis C virus infection. MK-5172/MK-8742 is an all-oral combination
regimen consisting of MK-5172, an investigational HCV NS3/4A protease
inhibitor, and MK-8742, an investigational HCV NS5A replication complex
inhibitor. Interim data from an ongoing Phase IIB clinical trial evaluating
MK-5172/MK-8742 in genotype 1 infected patients (C-WORTHY Study) is scheduled
to be presented at the 64^th American Association for the Study of Liver
Disease Annual Meeting, Washington D.C., Nov. 1-5.
“The designation of MK-5172/MK-8742 as a Breakthrough Therapy for chronic
hepatitis C is an important milestone for Merck,” said Dr. Roger M.
Perlmutter, president, Merck Research Laboratories. “There remains significant
unmet medical need in hepatitis C, and we are looking forward to working with
the FDA to advance this program as quickly as we can to bring this
investigational combination to HCV specialists and their patients.”
According to the FDA, the designation of an investigational drug as a
Breakthrough Therapy is intended to expedite the development and review of a
candidate that is planned for use, alone or in combination, to treat a serious
or life-threatening disease or condition when preliminary clinical evidence
indicates that the drug may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints.
Chronic hepatitis C is a priority focus of research and development at Merck.
MK-5172 and MK-8742 are being investigated in a broad clinical program that
includes studies in patients with multiple HCV genotypes who are
treatment-naïve, treatment failures as well as other important HCV
subpopulations such as patients with cirrhosis and those co-infected with HIV.
For more information please see www.clinicaltrials.gov.
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