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Hep C Discussion Forum -> Hep C News -> FDA Grants Breakthrough Designations to Merck’s Hepatitis C Candidate
Post Info TOPIC: FDA Grants Breakthrough Designations to Merck’s Hepatitis C Candidate
Tig


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RE: FDA Grants Breakthrough Designations to Merck’s Hepatitis C Candidate
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Hey Matt,

I was sent this information that expands a bit on the new MSD (Merck) offerings currently in the pipeline. This release offers some promising news regarding efficacy. It's from April, but the trial results are interesting. Also mentioned is the European Medicines Agency acceptance of a marketing application as well. Hopefully soon, another weapon in the HCV arsenal. 

Mercks Pivotal Phase 3 C-EDGE Program Evaluating Grazoprevir/Elbasvir Shows High

European Medicines Agency application accepted



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Matt Chris


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After rescinding breakthrough designation earlier this year, the FDA re-established two new designations for an oral combination tablet of grazoprevir/elbasvir for the treatment of chronic hepatitis C virus infection genotype 4 and genotype 1 with end stage renal disease on hemodialysis, according to a news release from the manufacturer.

The FDA originally granted breakthrough therapy designation for the drug combination in October 2013. However, in February, Merck announced the FDAs intent to rescind that designation due to the availability of other new drugs for HCV. The new breakthrough designations for grazoprevir and elbasvir (MK-5172, MK-8742; Merck) are geared towards treating patients with chronic HCV genotype 1 with end-stage renal disease on hemodialysis and patients with chronic HCV genotype 4, according to the release

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, Eliav Barr, MD, vice president, infectious diseases at Merck Research Laboratories, said in the release. 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.

Breakthrough therapy designation 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, according to the release.

At the 2014 Liver Meeting in Boston, phase 2 study results were presented that indicated the treatment regimen was safe and well tolerated among treatment-naive patients with HCV genotype 1 and cirrhosis and patients previously treated with pegylated interferon and ribavirin, with or without cirrhosis, after 12 or 18 weeks of therapy.

New data evaluating grazoprevir/elbasvir are scheduled to be presented at the 2015 International Liver Congress in Vienna, Austria, according to the release. by Melinda Stevens

The FDA has granted 2 breakthrough therapy designations to Mercks chronic hepatitis C virus (HCV) candidate, grazoprevir/elbasvir.
 
The once-daily, single-tablet regimen originally received breakthrough therapy status for the treatment of chronic HCV genotype 1 (GT1) infection in October 2013. However, the FDA rescinded it in January 2015.
 
Now, grazoprevir/elbasvir has been fast-tracked for FDA approval in chronic HCV GT1 infection in end-stage renal disease patients on hemodialysis, as well as patients with chronic HCV genotype 4 infection. 


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