SUNDAY, JUNE 17, 2018

Oral regimen for Hepatitis C treatment receives MAA validation

Marketing Authorization Applications (MAAs) for an all-oral, interferon-free regimen for the the treatment of adults with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection were recently validated and are now being assessed by the European Medicines Agency (EMA).

The regimen was granted accelerated assessment by the EMA in May. The regimen could be available to the EU in the first quarter of 2015, should it be approved in a review process.

The regimen was developed by Enanta and AbbVie using drug combinations of HCV protease-inhibitor-containing drugs, HCV NS3 and NS3/4A protease inhibitors. ABT-450, a protease inhibitor, was discovered in the collaboration.

Protease inhibitors affect the life cycle of HCV by preventing non-structural proteins from forming, preventing replication of the virus.

The development is part of a collaboration between Enanta and Abbott that was announced in December 2006. The agreement put AbbVie in charge of developing and commercializing ABT-450.

Enanta Pharmaceuticals uses a chemistry-driven approach to create small molecule drugs in the field of infectious diseases. Enanta has collaborated with companies to develop novel inhibitors for the hepatitis C virus. It also created Bicyclolides, a new class of antibiotic that treats multi-drug resistant bacteria.