Janssen's simeprevir (TMC435) - US FDA grants priority review

Related
May 13
U.S. FDA grants priority review to Simeprevir (TMC435) for combination treatment of genotype 1 chronic hepatitis C

Trial - Not yet recruiting
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
Conditions: Hepatitis C, Chronic; Infection
Interventions: Drug: TMC435; Drug: Pegylated interferon alfa-2a (PegIFNα-2a); Drug: Ribavirin (RBV)

April 23 - EASL
Findings from Two Phase 3 Studies of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients

Simeprevir (TMC435) with peginterferon-α2a or -α2b and ribavirin in treatment-naïve HCVgenotype 1 patients: QUEST-2, a randomised Phase III trial 

Simeprevir (TMC435) with peginterferon/ribavirin for chronic HCV genotype 1 infection intreatment-naïve patients: results from QUEST-1, a Phase III trial

US FDA grants priority review to Janssen's simeprevir
May 15

The US Food and Drug Administration (FDA) has granted Priority Review to Janssen Research & Development, LLC (Janssen) New Drug Application (NDA) 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 with compensated liver 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.

"Hepatitis C is a complex disease and Janssen is committed to working with the HCV community, caregivers and healthcare systems to address this global epidemic," said Gaston Picchio , Hepatitis Disease Area Leader, Janssen Research & Development. "We are pleased that the FDA has granted simeprevir Priority Review, as it is a significant step forward in making this therapy available to physicians and their hepatitis C patients."

The FDA grants Priority Review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. Under the Prescription Drug User Fee Act, FDA review will begin approximately 60 days after receipt of the application and will aim to be complete within six months from when the review period begins.

The regulatory submission for simeprevir is supported in part by data from three pivotal phase 3 studies: QUEST-1 and QUEST-2 in treatment-naive patients and PROMISE in patients who have relapsed after prior interferon-based treatment. Janssen also recently submitted simeprevir for marketing authorization to regulatory authorities in Japan and Europe.

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, including all stages of liver fibrosis. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.

Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is the focus of a rapidly evolving treatment landscape. Approximately 150 million people are infected with hepatitis C worldwide - including approximately 3.2 million people in the United States - and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver, including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.

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.