Merck Wins Back FDA Breakthrough Therapy for New Hep C Regimen

By John Lavitt 04/10/15

The goal of Merck is to create an HCV treatment drug regimen that can be broadly used.

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In a major turnaround, Merck has won back breakthrough status for its new hepatitis C treatment drug.

Although Merck initially achieved breakthrough status for their new HCV drug, the status was surprisingly rescinded in February. On April 8, however, the Food and Drug Administration changed their mind and designated breakthrough status for MK-5172/MK-8742, an investigational oral combination regimen for the treatment of chronic hepatitis C virus infection.

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 designed to treat a serious or life-threatening disease or condition. The designation is only given when the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The Merck combination oral regimen is composed of a new protease inhibitor combined with a replication complex inhibitor.

Interim data from the latest clinical trial of the regimen is scheduled to be presented at the 64th American Association for the Study of Liver Disease Annual Meeting in Washington D.C. at the beginning of November. Dr. Roger M. Perlmutter, president at Merck Research Laboratories, described the company’s satisfaction over receiving the FDA news.

“The designation of MK-5172/MK-8742 as a Breakthrough Therapy for chronic hepatitis C is an important milestone for Merck," Perlmutter said. "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.”

Chronic hepatitis C is a priority focus of research and development at Merck. The breakthrough treatment regimen is targeting patients with multiple HCV genotypes who are both treatment-naïve and treatment failures. In addition, other important HCV subpopulations such as patients with cirrhosis and those co-infected with HIV are being tested in the clinical trials as well. The goal of Merck is to create an HCV treatment drug regimen that can be used broadly to treat multiple genotypes experiencing multiple complications successfully.

“HCV remains a global public health epidemic. At Merck, we are focused on the development of an efficacious, well-tolerated, once-daily therapy that can be used to treat multiple genotypes and a diverse population of chronic HCV patients,” explained Dr. Eliav Barr, vice president of infectious diseases at Merck Research Laboratories. “Our clinical program is among the largest and most comprehensive, with studies dedicated to patient populations where significant unmet medical need still exists, such as prior treatment failures, as well as those living with co-morbid conditions, including HIV infection, chronic kidney disease and individuals on opiate substitution therapy.”

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Growing up in Manhattan as a stutterer, John Lavitt discovered that writing was the best way to express himself when the words would not come. After graduating with honors from Brown University, he lived on the Greek island of Patmos, studying with his mentor, the late American poet Robert Lax. As a writer, John’s published work includes three articles in Chicken Soup For The Soul volumes and poems in multiple poetry journals and compilations. Active in recovery, John has been the Treatment Professional News Editor for The Fix. Since 2015, he has published over 500 articles on the addiction and recovery news website. Today, he lives in Los Angeles, trying his best to be happy and creative. Find John on Facebook, Twitter, and LinkedIn.