Gilead wins FDA nod for pan-genotypic Hep C drug
- 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.
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.
- Wall Street Journal Gilead Gets FDA Approval for Combo Hepatitis C Drug
- Bloomberg Gilead’s New Hepatitis C Drug Approved by FDA, Priced at $74,760
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