The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to AbbVie’s investigational hepatitis C virus (HCV) regimen.
The designation was given based on results from the Phase II MAGELLAN-1 study of glecaprevir/pibrentasvir among people with genotype 1 of the virus who failed a previous treatment attempt.
The breakthrough designation is intended to expedite the development of glecaprevir/pibrentasvir as well as its FDA review process. It indicates that the FDA recognizes the treatment’s potential to offer a substantial improvement over existing hep C therapies.
Formerly known as ABT-493 and ABT-530, respectively, the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir have entered Phase III trials as a coformulated single-tablet regimen. AbbVie is testing the pangenotypic treatment (meaning it treats all genotypes of the virus) among participants with genotypes 1 through 6 of hep C.
To read a press release about the designation, click here.