FDA approved Gilead Sciences Inc.’s hepatitis C drug for all forms of the viral disease.
The drug, called Epclusa, can be used by patients with any of the six genotypes of hepatitis C.
Gilead has set a list price of $74,760 for a 12-week course of treatment, CEO John Milligan said via telephone. That’s lower than the list prices of its best-selling alternative Sovaldi, at $84,000, and Harvoni, $94,500.
“This is the best price for the system and the company,” said Milligan, noting that Sovaldi and Harvoni are now sold at significant discounts to their list prices.
In 2014, Gilead Sciences successfully launched Sovaldi and Harvoni, two hepatitis C drugs that transformed standard of care in this indication.
Prior to Sovaldi and Harvoni (a mash-up of Sovaldi and a second drug, ledipasvir), most hepatitis C patients got injection-based treatment that lasted 24 weeks or longer and often had significant side effects. Cure rates for prior-generation treatments were only about 80%.
With the launch of Sovaldi and Harvoni, treatment duration fell to 12 weeks (and sometimes less) for the majority of patients, and cure rates improved to mid 90%.
Although Gilead is dominating the hep C space, there is still steep competition from rivals AbbVie ($ABBV), Bristol-Myers Squibb ($BMY) and Merck ($MRK), with the increased demand for quicker, more effective drugs for the liver-destroying disease growing unabated.
But Gilead will wish to overcome its rivals as it’s the first to treat all adults with all genotypes (1-6) with HCV. The drug was also approved by European regulators earlier this year.
“The approval of Epclusa shows an important progress forward in the global effort to control and potentially get rid of HCV as it provides a safe, simple and effective treatment for the majority of HCV-infected patients, regardless of genotype,” said Dr. Ira Jacobson, chairman of the Department of Medicine at Mount Sinai Beth Israel in New York City and a principal investigator in the Epclusa clinical trials.
