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FDA approves Gilead’s Harvoni in two new indications

Published on 18/02/16 at 09:08am

The hepatitis C treatment battle had its latest development yesterday, with the FDA awarding Gilead Science’s market-leading drug Harvoni (ledipasvir/sofosbuvir) approval in two new indications and bringing it to an even broader group of patients.

The new approvals mean liver transplant hep C patients, as well as those with decompensated cirrhosis can now be treated with 12 weeks of all-oral therapy.

The Agency approved the blockbuster treatment in additional indications for patients with advanced liver disease: in combination with Ribavirin for 12 weeks in chronic hepatitis C virus (HCV) genotype one or four-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A); and for HCV genotype one-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation.  

“Hepatitis C-infected patients who have decompensated cirrhosis and those who have previously received a liver transplant have an urgent need for treatment, but historically their options have been limited,” says Norbert Bischofberger, executive vice president of Research and Development and chief scientific officer at Gilead. “We are pleased that health care providers now have the information needed to offer these patients an all-oral, 12-week duration therapy with high cure rates and a tolerable side effect profile.”

The hepatitis C treatment space is particularly competitive, as companies battle for sales, and is becoming even more so in the early part of 2016. The FDA recently approved MSD’s new combo Zepatier (elbasvir/grazoprevir) for treating genotypes one and four, and the company gave the drug a competitive price listing of $54,600 for a 12-week treatment course, some 40% below Harvoni’s $94,500 tag.

Joel Levy

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