Boston, MA 06/20/2014 (wallstreetpr) – Enanta Pharmaceuticals Inc (NASDAQ:ENTA) scored a new high on Thursday, after the shares of the company surged by more than 4% to close at $46.14. The optimism surrounding the company could be accredited to the recent announcement stating that the European Medicines agency has validated the Marketing Authorization Applications (MAAs) for AbbVie’s investigational, all-oral, interferon-free regimen.
MAAs Validated
The validation brings the company under the accelerated assessment by the European Medicines Agency. AbbVie’s regimen is primarily meant to address the chronic genotype 1 (GT1) hepatitis C virus (HCV) infection among adult patients. The three antiviral investigational regimens acting directly for GT1 comprises of the fixed dose of ABT -450/ritonavir and ombitasvir (ABT-267) 25 mg, as well as dasabuvir (ABT-333) 250 mg.ABT-450 is the company’s primary potease inhibitor formulated through it’s collaboration with AbbVie.
The accelerated assessment is a review process undertaken by the EMA for those medicines that carry a major public interest. The same was conferred to AbbVie’s investigational HCV medicine in May 2014. The validation of the MAAs establishes that the company’s submissions are complete in all manner and thus, would be put under EMA’s centralized review. If AbbVie gets success in terms of approval by the EMA, then it could start marketing the regimen in the European Union by as early as first quarter of 2015.
Marketing Authorization In The EU
