AbbVie’s new hepatitis C drug approved in Japan

US pharma major AbbVie (NYSE: ABBV) says that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Viekirax (ombitasvir/paritaprevir/ritonavir) as a new interferon and ribavirin-free treatment option for adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis.

The drug is already approved in the USA [trade name Viekira Pak] and Canada. Peak sales estimates for AbbVie’s hepatitis C drugs, and competes with Gilead Sciences’ (Nasdaq: GILD) Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) are around $3 billion a year. Combined, Gilead’s two new hepatitis C drugs generated sales of $4.9 billion for the second quarter of 2015 quarter, beating Deutsche Bank expectations of $4.27 billion. Harvoni sales came in at $3.6 billion and Sovaldi $1.3 billion.

"Today's approval represents an important step forward for the treatment of Japanese patients, a population with specific needs based on patient and viral characteristics," said Jean-Michel Pawlotsky, professor of medicine at the University of Paris-Est, France, adding: "Viekirax is a valuable new addition to a number of treatments that are changing the face of hepatitis C, making it possible to achieve high virologic cure rates, even in patients whose disease has progressed to compensated liver cirrhosis."