Janssen R&D Ireland (Janssen) has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients.
Simeprevir is a new generation, NS3/4A protease inhibitor administered as a once daily 150mg capsule with pegylated interferon (pegIFN) and ribavirin (RBV) offering proven efficacy across a range of different hepatitis C virus (HCV) patient types.
The CHMP opinion was based on positive and consistent results from three pivotal Phase 3 studies in patients with genotype 1 HCV: QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment. The studies involved over 1000 patients. QUEST-1 and QUEST-2 included 785 treatment-naïve patients with genotype 1 chronic HCV infection. PROMISE included 393 relapser patients with genotype 1 chronic HCV infection. All three studies met their primary end points and demonstrated simeprevir, in combination with pegIFN and RBV, achieves superior cure rates when compared with PegIFN and RBV alone, in treatment naïve and prior-relapser patients.[2,3]
Simeprevir is generally well tolerated, with the most common adverse events reported in clinical trials (incidence ≥ 5%) including nausea, rash, pruritus, dyspnoea, blood bilirubin increase and photosensitivity reaction.
HCV is a major health problem in the European Union, where nine million people are living with the disease. Treatment of HCV is complex because of the unpredictable course of the infection and the heterogeneous population of patients it affects. Treatment efficacy is also highly dependent on the genotype of the virus.
“The CHMP positive opinion for simeprevir brings us another step closer to delivering an innovative therapy for patients suffering from this devastating disease. Simeprevir offers a potentially new treatment option and therefore renewed hope to people living with HCV,” said Brian Woodfall, Head of Development & Global Medical Affairs, Infectious Diseases/Vaccines, Janssen.
A CHMP positive opinion is the last step prior to the European Commission potentially granting Marketing Authorisation to a medicinal product. It does not guarantee approval. A final decision on simeprevir by the European Commission is anticipated during the second quarter of 2014.
- Committee for Medicinal Products for Human Use (CHMP) report. Available from http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/002777/WC500163524.pdf Accessed March 2014.
- Forns X et al. Simeprevir with Peginterferon and Ribavirin Leads to High Rates of SVR in Patients with HCV Genotype 1 Who Relapsed After Previous Therapy: a Phase 3 Trial. Gastroenterology. 2014 Mar 3. pii: S0016-5085(14)00293-5. doi: 10.1053/j.gastro. 2014.02.051. [Epub ahead of print]
- Jacobson I et al. The QUEST 1 and 2 studies, abstract presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
- European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. Journal of Hepatology. 2011:55,245-264.