FDA News

FDA grants new breakthrough therapy designations for grazoprevir/elbasvir

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 FDA’s 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

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 FDA’s 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