AbbVie has been awarded breakthough status by the US FDA for a combination regimen for hepatitis C virus (HCV) infections currently in phase III testing.
The designation means the FDA considers the regimen likely to show substantial improvement over existing therapies and will be expedited through the regulatory review process.
AbbVie’s HCV regimen consists of three direct-acting antivirals – the protease inhibitor ABT-450 (boosted with ritonavir), NS5A inhibitor ABT-267 and non-nucleoside polymerase inhibitor ABT-333 – which are being positioned as an all-oral alternative to therapies based on injectable interferon alpha.
The combination is being tested in patients with genotype 1 (GT1) HCV infections and AbbVie is vying to bring it to market in 2014.
Analysts have predicted peak sales for the company’s HCV portfolio will be upwards of $2bn a year, which would be a major step towards reducing its reliance on arthritis drug Humira (adalimumab) which is due to start losing patent protection in 2016.
New data from the phase IIb AVIATOR study has shown that over 24 weeks the regimen achieved a sustained virologic response (SVR) in 99 per cent of treatment-naïve GT1 patients and 93 per cent of those who had failed interferon-based therapy when given alongside ribavirin.
The SVR rate for patients treated without ribavirin was around 87 per cent, and in all cases the efficacy of the regimen seemed to be unaffected by gender, HCV subtype, extent of liver disease and viral load.
AbbVie is in a race with a number of other companies to bring an all-oral HCV regimen to market, including Gilead Sciences and Boehringer Ingelheim, and Bristol-Myers Squibb/Vertex although some other companies have suffered setbacks in their own efforts.
In March Pfizer dropped HCV candidate filibuvir after a strategic review of its pipeline, while last year BMS abandoned its polymerase inhibitor BMS-986094 candidate after a patient death in trials.
“AbbVie is pleased that the FDA has granted breakthrough therapy designation to our triple-DAA combination, with and without ribavirin,” said John Leonard, AbbVie’s chief scientific officer.
“We feel it reflects the potential of this regimen to be important in the treatment of HCV,” he added.