FDA has granted priority review for AbbVie’s investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus infection.
Santilli
FDA has granted priority review for AbbVie’s investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus infection.
The regimen consists of ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without RBV. The combination of 3 different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response rates across different patient populations, according to a company press release.
“FDA’s acceptance of AbbVie's new drug application and granting a priority review for its all-oral regimen for treating adult patients infected with the hep C virus currently positions the company as runner-up in the $20 billion market to Gilead Sciences,” according to John Santilli, of Access Market Intelligence, which provides market intelligence to the pharmaceutical and healthcare industries.
The outlook for AbbVie as the second-largest participant is promising as its 3-drug regimen is estimated to reach $3 billion in sales, according to Santilli.
“However, AbbVie’s second place position in the market may be short-lived, as Merck has made an impact in the market with its combination drug entry,” he said.
An all-oral, once-daily regimen combining MK-5172, an investigational hepatitis C virus (HCV) NS3/4A protease inhibitor, and MK-8742, an investigational HCV NS5A replication complex inhibitor is being tested by Merck to treat hepatitis C.
Last week, Merck purchased biopharmaceutical maker Idenix Pharmaceuticals to help strengthen its hep C drug portfolio.
“The hep C market appears to be heading to a price war as the market backlash to Gilead's $1,000-a-pill Sovaldi continues and Merck, AbbVie, and Bristol-Myers Squibb compete aggressively on pricing,” Santilli said.
For more on hep C go to:
Chronic hep C: More effective, better-tolerated therapies still needed, researchers say
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More