AbbVie In Race Against Merck And Gilead For HCV Treatment
By Cyndi Root
AbbVie announced in a press release that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for its treatment for genotype 1 (GT1) hepatitis C virus (HCV) infection. AbbVie is in a race with Gilead and Merck to provide an effective combination treatment for HCV. Gilead has an NDA before the FDA for antiviral Sovaldi with NS5A inhibitor ledipasvir. Merck's combination of MK-5172 and MK-8742 has shown significant cure rates.
Scott Brun, M.D., VP of Pharmaceutical Development at AbbVie said, "Based on the robust data that have been generated in our international Phase III HCV program, we believe our all-oral, interferon-free regimen holds the potential to be a promising new therapy for patients living with this chronic infection."
AbbVie's Investigational HCV Regimen
Over three million people are living with HCV in the U.S. During a collaboration of AbbVie and Enanta Pharmaceuticals to research hepatitis C virus protease inhibitors, investigators discovered ABT-450. The AbbVie investigational regimen is a combination of agents. Patients take ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333). AbbVie supported its NDA with six Phase III clinical trials of over 2,300 patients in more than 25 countries. The goal of the studies was to optimize the doses across different populations. AbbVie is studying ABT-450 with other agents and will apply to the European Medicines Agency (EMA) for regulatory approval of the investigational agent and its combination uses.
Gilead HCV Program
Gilead Sciences announced in February that it submitted an NDA to the FDA for a combination of ledipasvir and sofosbuvir (brand name Sovaldi) for HCV treatment. The FDA approved Sovaldi last year for HCV but Gilead is currently under scrutiny by the federal legislative branch, insurers, and the public due to the high cost of Sovaldi.
Merck's MK-5172 and MK-8742
At the recent International Liver Congress, Merck's disclosed results of a study of a combination of MK-5172 and MK-8742 for genotype 1 HCV patients. The company said that 98 percent of patients were cured at 12 weeks. While this drug combination may not be approved until 2016, it poses strong competition for AbbVie’s and Gilead’s products.