Medivir AB today announced that a new drug application (NDA) has been filed with the U.S. Food and Drug Administration (FDA) seeking approval for simeprevir. The filing is based on phase III data in treatment-naïve and treatment-experienced patients with compensated liver disease.
The filing of a regulatory application in the US triggers a milestone payment of €10m to Medivir.
Simeprevir is jointly developed by Medivir and Janssen Pharmaceuticals, Inc. (Janssen), and is an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients.
“The filing in the U.S. is a very important milestone for simeprevir, the hepatitis C patients and for Medivir as a company. In addition it triggers a € 10m milestone payment to us, which strengthens our solid financial situation even more.” comments Maris Hartmanis, CEO of Medivir.
The regulatory submission for simeprevir is supported in part by data from three pivotal phase III studies: QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment. In each study, participants were treated with one 150 mg simeprevir capsule once daily for 12 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks. Primary efficacy data from the phase III studies will be presented at different upcoming medical meetings.