AbbVie Inc (ABBV) recently declared that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted priority review for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), being evaluated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C virus (HCV). The FDA grants priority review designation to medicines that it determines have the potential to provide noteworthyimprovements in the safety and effectiveness of the treatment of a serious disease. The NDA is supported by data from eight registrational studies in AbbVie’s G/P clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes and for special populations.
“We are happy that G/P has been granted priority review by the FDA. We will continue to work closely with the agency as they review our New Drug Application and we remain committed to bringing a new cure to patients with chronic hepatitis C,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.
Bristol-Myers Squibb Co (BMY) develops, licenses, manufactures, markets, and distributes biopharmaceutical products worldwide. It offers chemically-synthesized drug or small molecule, and biologic in various therapeutic areas, counting virology comprising human immunodeficiency virus infection (HIV); oncology; immunoscience; cardiovascular; and neuroscience. Its products include Baraclude for the treatment of chronic hepatitis B virus infection; Daklinza and Sunvepra for the treatment of hepatitis C virus infection; Reyataz and Sustiva for the treatment of HIV; Empliciti, a humanized monoclonal antibody for the treatment of multiple myeloma; Erbitux, an IgG1 monoclonal antibody that blocks the epidermal growth factor receptor; Opdivo, a fully human monoclonal antibody for non-small cell lung and renal cell cancer, and melanoma; Sprycel, a tyrosine kinase inhibitor for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia; Yervoy, a monoclonal antibody for metastatic melanoma; Abilify, an antipsychotic agent for adults with schizophrenia, bipolar mania disorder, and depressive disorder; Orencia to treat rheumatoid arthritis; and Eliquis, an oral factor Xa inhibitor targeted at stroke prevention in atrial fibrillation. Its products pipeline includes Beclabuvir, a non-nucleoside NS5B inhibitor for the treatment of HCV; BMS-663068, an investigational compound that is being studied in HIV-1; and Prostvac, a Phase III prostate-specific antigen to treat asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. The company has clinical trial collaborations with Calithera Biosciences, Inc. and Janssen Biotech, Inc.; and a research partnershipwith GeneCentric Diagnostics, Inc. The company was formerly known as Bristol-Myers Company and changed its name to Bristol-Myers Squibb Company in 1989. Bristol-Myers Squibb Company was founded in 1887 and is headquartered in New York, New York.