Janssen submits Marketing Authorization Application to EMA for simeprevir approval

Medivir AB (OMX: MVIR) (STO:MVIR-B) today announces that Janssen-Cilag International NV (Janssen) today has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) seeking approval for simeprevir (TMC435).

"The filing of simeprevir in Europe represents the third filing in major regions in the last two months. It shows the commitment and speed with which our partner Janssen acts in the process of bringing new hepatitis C treatments to the market", said Maris Hartmanis, CEO of Medivir AB.

The regulatory submission for simeprevir is supported by data from three phase III studies in patients with genotype 1 hepatitis C: QUEST-1 and QUEST-2 in treatment-naïve patients, and PROMISE in patients who have relapsed after prior interferon-based treatment. The filing for the treatment of patients with the genotype 4 virus is based on phase II data and an ongoing phase III study.

Simeprevir is a new generation NS3/4A protease inhibitor, administered as a capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 and 4 chronic hepatitis C in adult patients. Genotype 1 is the most prevalent form of hepatitis C virus (HCV) worldwide.

SOURCE Medivir AB

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Vaccines and virus changes cut long COVID risk by 50%, but Omicron still poses a threat