Janssen Submits Approval Requests for New Hepatitis C Drug Simeprevir

Details
Category: HCV Treatment
Published on Wednesday, 24 April 2013 00:00
Written by Janssen
alt

Janssen has submitted requests for approval in the U.S. and Europe for its investigational HCV protease inhibitor simeprevir (formerly TMC435) as an addition to interferon-based therapy for people with genotype 1 or 4 chronic hepatitis C virus infection. The company announced that it filed a New Drug Application with the U.S. Food and Drug Administration (FDA) on March 28, followed by a Marketing Authorisation Application to the European Medicines Agency (EMA) on April 24.

As described in a press release announcing the EMA application, "Simeprevir is a new generation NS3/4A protease inhibitor, administered as one capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 or genotype 4 chronic hepatitis C in adult patients with compensated liver disease (including cirrhosis), with or without HIV-1 coinfection, who are treatment naive or who have failed previous interferon therapy."

In studies to date, simeprevir has demonstrated favorable sustained response rates compared with pegylated interferon/ribavirin alone for both treatment-naive patients (QUEST-1 and QUEST-2) and those who were not cured with prior interferon-based therapy (PROMISE). Data from these trials will be presented at the EASL International Liver Congress taking place this week in Amsterdam. Simeprevir has also shown promising early efficacy in various interferon-free combinations, including simeprevir plus sofosbuvir (formerly GS-7977) with or without ribavirin.

Below is an edited excerpt from a recent Janssen press release announcing the U.S. submission

Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C

Raritan, N.J. -- March 28, 2013-- Janssen Research & Development, LLC (Janssen) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for simeprevir (TMC435), 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.

"Hepatitis C is a complicated disease and genotype 1 hepatitis C can be particularly difficult to cure. Given the complexity and diversity of the patient population, physicians need multiple options to provide their patients a chance at treatment success," said Wim Parys, Global Head of Development, Infectious Diseases and Vaccines, Janssen. "The U.S. filing represents an important step forward in bringing simeprevir to market and in helping to battle this challenging disease."

Hepatitis C virus (HCV) is a blood-borne infectious disease of the liver that affects approximately 3.2 million people in the United States. When left untreated over time, HCV can cause significant damage to the liver, including cirrhosis.

The regulatory submission for simeprevir is supported in part by data from three pivotal Phase 3 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 3 studies will be presented at an upcoming medical meeting.

About Simeprevir

Simeprevir (TMC435) is an investigational NS3/4A protease inhibitor jointly developed by Janssen and Medivir AB for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. Simeprevir is believed to work by blocking the protease enzyme that enables the hepatitis C virus to survive and replicate in host cells.

For additional information about simeprevir clinical studies, please visit www.clinicaltrials.gov.

About Janssen Research & Development, LLC

Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism. For more information about Janssen Research & Development, LLC visit www.janssenrnd.com.

4/24/13

Sources

Janssen. Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C. Press release. March 28, 2013.

Janssen. Janssen Submits Marketing Authorisation Application for Simeprevir (TMC435)to the European Medicines Agency for the Treatment of Adult Patients with Chronic Hepatitis C Genotype 1 or Genotype 4. Press release. April 24, 2013.