Telaprevir takes a leap towards the HCV market while boceprevir appears to be crawling over the line

HCV news hot off the press from Maryland: We now have positive opinions on two HCV candidates in two days.

Yesterday boceprevir gained unanimous approval from the FDA's ADCOM panel, today it was the turn of telaprevir. Although both agents gained unanimous approval, telaprevir seems to have come out of the review process more favourably with response guided therapy lauded in both treatment experienced and naive patients. Response guided therapy will likely mean shorter overall treatment with telaprevir (vs boceprevir) in treatment experienced patients (24 weeks vs a likely 32 weeks).

In addition telaprevir appears likely to be approved in null responders, while it remains questionable whether boceprevir will even get an indication for null responders based on currently available data.

So, despite a unanimous approval boceprevir does not, on first glance appear to have come out shining. Some sources even suggest that the PDUFA date may be longer for boceprevir or that it may ever get a CRL due in part to an apparent oversight with respect to drug interaction studies.

Sources:

• FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C
• VICTRELIS™ (boceprevir) Unanimously Recommended for Approval by FDA Advisory Committee for Treatment of Chronic HCV Genotype 1 Infection

Further reading:

• R&D Trends: Hepatitis C
• Epidemiology: Hepatitis C - Hepatitis C virus will remain a prevalent bloodborne disease in the seven major markets, primarily transmitted through injection drug use