The FDA has granted priority review status to
) experimental all-oral, interferon-free therapy for the treatment
of adults with chronic genotype 1 (GT1) hepatitis C virus (HCV)
With the new drug application (NDA) being submitted on Apr 21,
AbbVie should receive a response from the FDA early in the fourth
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
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 -
) 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
) 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.
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