- Grazoprevir/elbagavir, an investigational single tablet regimen (STR) for hepatitis C, has won a new Breakthrough Therapy designation based on strong clinical data for treatment of chronic HCV genotype 4 (GT4).
- Merck has generated a tremendous amount of clinical data on its HCV candidate and will be presenting 14 abstracts at the upcoming International Liver Congress.
- Merck recently was stripped of the Breakthrough Therapy Designation that it received in October 2013 for its HCV candidate as a treatment for HCV genoptye 1 (GT1). There was no longer an unmet medical need for a GT1 treatment once Gilead's Sovaldi (sofosbuvir) became available.
Even though Merck lost Breakthrough Therapy Designation for its HCV candidate in the treatment of CV GT1, it still has two Breakthrough Therapy Designations, including the most recent designation, as well as Breakthrough Therapy Designation for treatment of patients infected with chronic HCV1 GT1 with end-stage renal disease.
Breakthrough Therapy Designation provides pharma companies the ability to expedite the R&D process because of additional support from the FDA, as well as an expedited review process. However, Breakthrough Therapy Designation is only for drugs that the FDA has deemed useful in treating a serious or life-threatening condition when preliminary clinical evidence indicates that the drug may demonstrate susbtantial improvement over existing therapies on one or more clinically significant endpoints.
Given the ambitious scope of Merck's HCV clinical trial program, there is substantial benefit associated with an expedited FDA review timeline. The International Liver Congress will be held from April 22 to April 26 in Vienna, Austria.