MSD gets FDA approval for hepatitis C drug Zepatier
pharmafile | January 29, 2016 | News story | Medical Communications, Sales and Marketing | FDA, MSD, Zepatier, hepatitis C
The competitive hepatitis C market is to get another contender, with FDA approving MSD’s new combo treatment Zepatier (elbasvir and grazoprevir) to treat genotypes one and four of the virus, with or without ribavirin.
In the short-term, Zepatier (elbasvir and grazoprevir) will compete with such therapies as Gilead Science’s Solvadi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir), as well as AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) and Technivie (ombitasvir, paritaprevir and ritonavir).
MSD confirmed that the list price for Zepatier will be $54,600 for a 12-week regimen, which it says is comparable with other commonly-used HCV direct-acting antiviral regimens at 12 weeks of therapy, and will help increase patient access. By comparison, Harvoni has a list price of $94,500 for the same treatment duration.
Zepatier’s approval follows a priority review by the US regulator, which in turn followed its awarding breakthrough therapy designations for the drug in the two separate genotypes. Zepatier achieved high rates of sustained virologic response across multiple clinical studies, ranging from 94 to 97% in genotype one (GT1)-infected patients, and 97 to 100% in genotype four (GT4)-infected patients.
Sustained virologic response is defined as a measure of HCV RNA levels at 12 weeks after the cessation of treatment (SVR12), indicating that the virus is not detectable in the blood and that a patient’s HCV infection has been cured.
“Continued innovation is needed to help address the worldwide epidemic of chronic hepatitis C virus infection,” says Dr Roger Perlmutter, president, Merck Research Laboratories. “Our clinical program was designed to study a broad range of patients infected with the hepatitis C virus, including difficult-to-treat patients such as those with stage 4 or 5 chronic kidney disease. The approval of Zepatier is a testament to Merck’s unwavering commitment to improving therapy for patients with hepatitis C virus infection, and we are eager to bring this innovation to patients and physicians in the United States.”
Zepatier was approved with a treatment duration of 12 or 16 weeks, depending on HCV genotype, prior treatment history and, for patients with GT1a infection, the presence of certain baseline NS5A polymorphisms. A 12-week, once-daily regimen is recommended for the vast majority of patients.
Joel Levy
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