Gilead wins FDA nod for hepatitis C ‘silver bullet’

US health regulators on Tuesday approved a combination drug by Gilead Sciences Inc that is the first available treatment for all six major forms of hepatitis C, advancing the company's leadership in the field and sending its shares up more than 4 per cent.

Gilead said in a separate statement that it priced the drug at $74,760 for a 12-week course.

Gilead has dominated the hepatitis C market over rivals AbbVie and Merck & Co with its high-priced but highly effective treatments Sovaldi and the combination drug Harvoni. The new treatment, to be sold under the brand name Epclusa, combines Sovaldi (sofosbuvir), which was approved in 2013, with a new anti-viral drug velpatasvir.

Epclusa costs less than the $84,000 that Sovaldi sold for when it launched in late 2013. Gilead now offers discounts and rebates on that older drug, which was at the centre of a national uproar over soaring drug costs.

Epclusa is approved for patients with and without cirrhosis, a form of scarring seen in patients with advanced disease that can lead to liver failure and need for a transplant. For those with moderate to severe cirrhosis, Epclusa must be taken with the older drug ribavirin, the Food and Drug Administration said.

"This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C," Edward Cox, director of the FDA's Office of Antimicrobial Products, said in a statement.

While the majority of US patients have the genotype 1 form of hepatitis C, about 20 per cent to 25 per cent have genotypes 2 or 3, with small numbers infected with genotypes 4, 5 or 6. In other parts of the world, other genotypes are far more prevalent, such as in Egypt, where genotype 4 is widespread.

In pivotal clinical trials, Epclusa led to cure rates of 95 per cent to 99 per cent in patients without or with mild cirrhosis after 12 weeks of treatment. In a separate trial of patients with moderate to severe cirrhosis, cure rates of 94 per cent were seen.