Get set for even more competition in the hepatitis C space. AbbVie’s Mavyret picked up FDA approval on Thursday as an 8-week treatment regardless of genotype, becoming the first such drug with the indication. When it hits the market, expect the new drug to take another slash at pricing in hep C.
A combo of two new direct-acting antivirals, glecaprevir and pibrentasvir, AbbVie’s drug won FDA approval to treat adult hep C patients with genotype 1 through 6 who don’t have cirrhosis or with mild cirrhosis, or those who are on dialysis. It’s the first pan-genotypic hep C drug with an eight-week treatment duration, according to the FDA. Other options cure the disease in 12 weeks or longer.
Mavyret’s approval means even more competition for Gilead Sciences. Its sales have been hit hard in recent years as its stalwarts Harvoni and Sovaldi ceded share, and pricing power, to new competition from AbbVie and Merck as payers pitted drugmakers against each other in a pricing war.
But in the second quarter of this year, Gilead significantly beat analyst consensus estimates for its hep C business, posting $2.86 billion in sales to beat expectations by $567 million. Gilead also has pan-genotypic drugs Vosevi and Epclusa, though those have a longer treatment duration.
According to AbbVie’s release, up to 95% of hep C patients in the U.S. may be eligible for treatment with Mavyret. About 3.4 million Americans are living with hep C, according to the drugmaker. In a recent report, life science commercial intelligence firm Evaluate predicted the new treatment will grow to $1.25 billion in sales by 2022.
Mavyret’s price is $13,200 per month or $26,400 per treatment course before discounts for most patients, according to a Thursday note from Evercore ISI analyst Umer Raffat. That’s significantly lower than other monthly prices, such as $28,000 per month for Sovaldi, $31,500 per month for Harvoni and $27,773 for AbbVie’s own Viekira Pak and Viekira XR. Merck’s Zepatier is priced at $18,200 per month. All prices listed are before discounts and rebates. Importantly, Mavyret boasts the shortest treatment duration of the group.
After Gilead raked in a fortune on its next-gen hep C entrants in years past, new competition has taken a toll on financial prospects for all players in the field. Merck was even forced to take a $2.9 billion writedown earlier this year on an experimental hep C drug.
AbbVie’s new drug also garnered a green light for patients with genotype 1 who have previously been treated with an NS5A inhibitor such as Bristol-Myers Squibb’s Daklinza or an NS3/4A protease inhibitor. A spokesperson said on Thursday the drug will be available "within days."
In addition to the U.S., AbbVie recently won approval for its new combo drug in Europe, according to the drugmaker’s release.