Gilead’s New Hep C Treatment Gets FDA Approval

Gilead’s robust hepatitis C drug portfolio got a major boost last week when the FDA approved Harvoni to treat genotype 1 chronic hepatitis C.

Harvoni (ledipavsir 90 mg/sofosbuvir 400 mg) is the first genotype 1 hepatitis C treatment that can be taken only once a day and doesn’t require the patient to also take interferon and ribavirin, which can be challenging for patients to take and tolerate, Gilead said.

The drug is indicated for an eight, 12 or 24 weeks course of treatment depending on prior treatment history, whether the patient has cirrhosis and the severity of the virus, Gilead said.

The average price for Harvoni varies from $63,000 for eight weeks of treatment to $94,500 for 12 weeks, according to a research note from Mark Schoenebaum, an analyst with International Strategy & Investment Group. Schoenebaum did not provide a price for the 24-week duration, but noted that a majority of patients will take either an eight or 12-week regimen.

The price appears to be on par with Gilead’s massively successful hepatitis C treatment Sovaldi, which costs $84,000 for a full treatment and $1,000 a pill. Gilead has weathered Congressional criticism surrounding the high price. Sovaldi quickly became a blockbuster for Gilead, generating $3.48 billion in sales in the second quarter of this year.

Gilead also defended the price of Harvoni. It is a cure at a price that will significantly reduce hepatitis C treatment costs now and deliver significant healthcare savings to the healthcare system over the long-term, spokeswoman Michele Rest said.

Harvoni’s approval was supported by three phase III clinical trials that evaluated the eight, 12 and 24-week treatment durations, Gilead said. Harvoni achieved cure results of 94 to 99 percent of patients enrolled in the trials, the drugmaker added. Harvoni received a faster review period through the FDA’s breakthrough therapy designation program, becoming the seventh new drug to get approved under the program since its inception in 2012.

Gilead also appears close to winning European approval after a positive recommendation from European Medicines Agency advisors last month. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.