The European Medicines Agency (EMA) has fully validated and granted accelerated assessment to Boehringer Ingelheim's application for European marketing authorization of faldaprevir, a potent second generation oral protease inhibitor.
Boehringer Ingelheim is seeking marketing authorization for 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.
The EMA marketing authorization application is based on a comprehensive clinical development program for faldaprevir with a particular focus on the recently presented Phase III STARTVerso trial data.
Patients with GT-1 hepatitis C who have not received previous treatment (treatment-naive: STARTVerso1 and 2), treatment-experienced patients (STARTVerso 3), and HIV co-infected patients (STARTVerso 4) have participated in this study program.
In STARTVerso1 and 2, 84% of treatment-naive patients receiving faldaprevir were able to shorten the total time on treatment from 48 to 24 weeks; 83% of these patients achieved viral cure (SVR12). Overall, 73% and 72% of patients achieved SVR12 with faldaprevir 120mg and 240mg regimens, respectively.
Interim results from STARTVerso 4 showed that 74% of patients with HCV/HIV co-infection treated with faldaprevir had undetectable HCV four weeks after the conclusion of treatment (SVR4), a response rate similar to that seen with HCV mono-infection.
Additionally, treatment of difficult-to-cure patients who have relapsed on previous HCV treatment (STARTVerso 3) demonstrated viral cure rates of 70% with faldaprevir. In the same study, patients who partially responded and those who showed no response to previous treatment achieved viral cure rates of up to 58% and 33%, respectively.
Boehringer Ingelheim corporate senior vice president medicine Dr Klaus Dugi noted 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. 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," Dr Dugi added.
EMA's 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.
If faldaprevir receives the European Commission marketing approval, the drug could be available in the EU in the second half of 2014.