The FDA has granted priority review status to AbbVie’s (ABBV - Analyst Report) experimental all-oral, interferon-free therapy for the treatment of adults with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.
With the new drug application (NDA) being submitted on Apr 21, AbbVie should receive a response from the FDA early in the fourth quarter.
The experimental HCV regimen has Breakthrough Therapy status which was granted by the FDA in May 2013. Breakthrough Therapy status, a new designation that became effective after Jul 9, 2012, is designed to cut short the development time of promising new treatments.
The HCV regimen has also been submitted for review in the EU where the marketing application was filed in May.
AbbVie’s HCV regimen comprises ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without ribavarin. AbbVie has presented impressive data on the experimental regimen and the NDA includes data from six phase III studies. First-round approval could very well result in this new treatment hitting the market by year end.
The HCV market is attracting a lot of interest - Gilead’s (GILD - Analyst Report) Sovaldi has been bringing in billions of dollars within a few months of its approval despite concerns regarding its high price. Plus there is space in the market for additional treatments. Interest in the HCV market increased further with pharma giant Merck (MRK - Analyst Report) recently announcing its intention to acquire HCV focused Idenix Pharmaceuticals, Inc. for about $3.85 billion.
Several companies are looking to bring the next generation of HCV treatments to market. Gilead itself is looking to get its once-daily fixed-dose HCV cocktail treatment -- ledipasvir (NS5A inhibitor) plus Sovaldi (nucleotide analog polymerase inhibitor) -- approved in the U.S.
AbbVie is a Zacks Rank #3 (Hold) stock. Gilead, which carries a Zacks Rank #1 (Strong Buy), is a better-ranked stock.