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FDA grants breakthrough designation to regimen for patients who fail DAA therapy
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The FDA has granted breakthrough therapy designation to AbbVie’s investigational regimen for patients with hepatitis C virus infection who failed previous direct-acting antiviral therapy, the manufacturer announced.
The pangenotypic regimen — ABT-493 (glecaprevir, AbbVie) and ABT-530 (pibrentasvir, AbbVie) — is for patients with HCV genotype 1 who failed treatment with DAAs, including treatment with an NS5A inhibitor and/or protease inhibitor, according to a press release. The designation is indicative of clinical results from the phase 2 MAGELLAN-1 clinical study.
“The FDA’s Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an 8-week path to virologic cure for the majority of patients,” Michael Severino, MD, executive vice president, research and development and chief scientific officer, at AbbVie, said in the release.
In the MAGELLAN-1 study, which was presented in April at the International Liver Congress, results from the regimen showed sustained virologic response rates around 90% in a cohort of treatment-experienced patients, including those with resistance-associated variants. Of this cohort, half had failed therapy on an NS5A drug, and 84% had failed on a protease inhibitor.
The regimen consists of the two drugs dosed once daily as three oral tablets, according to the release.
Phase 3 clinical data on this regimen will be presented at an upcoming scientific conference, according to AbbVie.
Disclosure: Severino is employed by AbbVie.