Back HCV Treatment HCV Protease Inhibitor Simeprevir Granted FDA Priority Review Status

HCV Protease Inhibitor Simeprevir Granted FDA Priority Review Status

alt

On May 13, Janssen announced that its application for approval of the next-generation hepatitis C virus NS3/4A protease inhibitor simeprevir (formerly TMC435) has received priority review status from the U.S. Food and Drug Administration (FDA), giving it an estimated timeline of 6 months.

The company submitted an FDA New Drug Application in late March, followed by a similar request to the European Medicines Agency, seeking approval of once-daily simeprevir in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C. The application is supported by data from the Phase 3 QUEST-1 and QUEST-2 trialsof previously untreated patients and the PROMISE trial of prior interferon relapsers (to be presented at Digestive Disease Week next week in Orlando).

Gilead's HCV polymerase inhibitor sofosbuvir (previously GS-7977) has also been submitted for approval with a 6-month estimated timeline, and AbbVie announced last week that the FDA has designated its interferon-free regimen of ABT-450/ritonavir, ABT-333, and ABT-267 as a "breakthrough therapy."

Below is an edited excerpt from a recent Janssen press release describing the FDA action.

U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C

Raritan, N.J., May 13, 2013 -- Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the 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.

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

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

About Hepatitis C

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.

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.

5/15/13

Source

Janssen Research & Development. U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C. Press release. May 13, 2013.