Hepatitis C: Boehringer Ingelheim’s faldaprevir granted accelerated assessment from European Medicines Agency

• Accelerated assessment reserved for medicinal products of major interest from the viewpoint of public health and therapeutic innovation¹
• Submission based on comprehensive development programme including the Phase III STARTVerso™ data aiming to demonstrate the efficacy and safety of faldaprevir* + PegIFN/RBV in a broad range of genotype-1 infected hepatitis C patients^2,3,4

The application for European marketing authorisation of faldaprevir*, a potent second generation oral protease inhibitor, has been fully validated and granted accelerated assessment by the European Medicines Agency (EMA).^5,6 Boehringer Ingelheim is seeking marketing approval of faldaprevir* in combination with pegylated interferon and ribavirin (PegIFN/RBV) for the treatment of a broad range of patients with genotype-1 (GT-1) hepatitis C, including difficult-to-cure populations such as those with HIV co-infection or advanced liver disease.

“Faldaprevir* has been studied with pegylated interferon and ribavirin in a broad range of more than 3,300 patients typical of those that doctors see in every day clinical practice. Faldaprevir* has demonstrated strong efficacy and a robust safety profile while also offering the convenience of once-daily dosing and no food restrictions,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. “The acceptance for accelerated assessment by the EMA supports our position that if approved, faldaprevir* will provide an important alternative to currently available hepatitis C treatments.”

Accelerated assessment status does not automatically lead to a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) or the granting of a marketing authorization by the European Commission.¹ If approved by the European Commission, faldaprevir* could be available for marketing in the EU in the second half of 2014.

The EMA Marketing Authorisation Application is based on a comprehensive clinical development programme for faldaprevir* with a particular focus on the Phase III STARTVerso™ trial data, recently presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). These studies include data for faldaprevir* in:

• Treatment naïve patients with the majority having benefited from shorter treatment duration and achieved viral cure²
• Difficult-to-cure patient populations such as those with HIV co-infection4 or advanced liver disease^2,3
• Patients with the Q80K polymorphism (this mutation is considered to affect the efficacy of other second generation protease inhibitors)²
• Treatment experienced patients who have relapsed, partially responded or failed to respond to previous therapy³

For full results see the STARTVerso™ press release here.

Faldaprevir* is the foundation of Boehringer Ingelheim’s hepatitis C treatment pipeline and is being developed in combinations both with and without interferon. In addition to the interferon-based faldaprevir* regimen that has been submitted for marketing approval, Boehringer Ingelheim aims to deliver one of the first interferon-free regimens for the treatment of hepatitis C infection. The goal is to make an interferon-free future a reality for a broad range of hepatitis C patients. Pivotal Phase III HCVerso® data for the interferon-free regimen of faldaprevir*, deleobuvir* and ribavirin will be available in 2014.

References

1. European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) Guideline on the procedure for accelerated assessment pursuant to article 14 (9) of regulation (EC) No 726/2004
2. Jensen, D. et al. A pooled analysis of two randomized, double-blind placebo-controlled Phase III trials (STARTVerso1&2) of faldaprevir plus pegylated interferon alfa-2a and ribavirin in treatment- naïve patients with chronic hepatitis C genotype-1 infection. Presented at The Liver Meeting®, the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 – 5 November, 2013
3. Jacobson, I. et al. STARTVerso3: A randomized, double-blind, placebo-controlled Phase III trial of faldaprevir in combination with pegylated interferon alfa-2a and ribavirin in treatment-experienced patients with chronic hepatitis C genotype-1 infection. Presented at The Liver Meeting®, the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 – 5 November, 2013
4. Rockstroh, J. et al. STARTVerso 4 Phase III trial of faldaprevir plus peg interferon alfa-2a and ribavirin (PR) in patients with HIV and HCV genotype 1 co-infection: end of treatment response. Presented at The Liver Meeting®, the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD),1 – 5 November, 2013
5. Boehringer Ingelheim Data on file. European Medicines Agency, Human Medicines Evaluation Division. (Faldaprevir Boehringer Ingelheim, Boehringer Ingelheim International GmbH). Submission validation, 21 November, 2013
6. Boehringer Ingelheim Data on file. European Medicines Agency, Human Medicines Evaluation Division. (Faldaprevir Boehringer Ingelheim, Boehringer Ingelheim International GmbH). Accelerated assessment acceptance, 12 November, 2013