Dive Brief:
- Gilead's pan-genotypic hepatitis C drug won approval from the Food and Drug Administration on Tuesday, likely further cementing the company's dominance of the market.
- Called Epclusa, the drug is the first approved treatment for all six genotypes of the liver disease. Genotype 1 is the most common version, but around 20-25% of Americans are infected with genotypes 2 or 3, according to the FDA.
- Despite the broader label for Epclusa, Gilead has reportedly priced the drug at $74,760 for a 12-week course of treatment, which is around $10,000 to $20,000 less than the current list prices for Harvoni and Sovaldi.
Dive Insight:
Gilead has come under fire for the high list prices for Harvoni and Sovaldi, particularly as drug prices have become a flash point for the industry in recent years.
Both drugs are highly effective in treating hepatitis C, curing nearly all patients of the disease. But Sovaldi lists for around $84,000, while Harvoni costs $94,500 per treatment course before discounts and rebates.
Despite the cost concerns, Harvoni and Sovaldi raked in nearly $20 billion in combined worldwide sales last year and have buoyed Gilead to the top of the hepatitis C market.
Yet first quarter results revealed a chink in Gilead's armor, as U.S. sales of Harvoni dropped by over half, and global sales fell by 15%. (Sovaldi sales grew due to approval in Japan.) Analysts have been concerned the overall market for hepatitis C is shrinking as new anti-viral treatments, including Gilead's drugs, cure the easiest-to-treat patients.
Rival drugmaker Merck has also been working to chip away at Gilead's lead, and priced its drug Zepatier competitively at $54,600 per treatment course. Zepatier is approved to treat genotypes 1 and 4, while AbbVie's Viekira Pak is only cleared to treat genotype 1.
Tuesday's Epclusa approval will open up a new treatment option for patients with genotypes 2 and 3, which were previously treated with a combination of Sovaldi and Bristol-Myers Squibb's Daklinza, according to Bloomberg.
Three phase trials showed Epclusa eliminated detectable virus in the blood 12 weeks post-treatment in between 95% and 99% of patients.
The FDA approved Epclusa to treat hepatitis C in patients both with or without cirrhosis. For patients with moderate-to-severe cirrhosis, however, Epclusa is approved only for use in combination with ribavirin.
Epclusa also carries a warning that treatment can lead to serious slowing of the heart rate when used in patients taking amiodarone, a heart drug.