An all-oral treatment regimen for hepatitis C virus developed by Bristol-Myers Squibb (BMS) has been awarded breakthrough status by the US FDA.
The combination of NS5A replication complex inhibitor daclatasvir and NS3 protease inhibitor asunepravir – given with or without hepatitis treatment stalwart ribavirin – is currently in a phase III trial involving patients with genotype 1b chronic HCV infection.
The breakthrough designation speeds up the development and review of new drugs and has been granted by the FDA on the strength of that ongoing phase III study, which should generate results later this year.
Daclatasvir also has breakthrough status for an all-oral regimen of daclatasvir, asunaprevir and hepatitis C polymerase inhibitor BMS-791325.
With BMS, Gilead and other companies such as AbbVie and Boehringer Ingelheim jostling to reach the market with all-oral treatment regimens, anything that accelerates time to market could be an advantage.
In addition to use as a component of BMS’ in-house combinations, daclatasvir could also piggyback on the EU approval of Gilead Sciences’ NS5B polymerase inhibitor Sovaldi (sofosbuvir), despite the latter company’s reluctance to participate in combination studies of the two drugs.
Gilead would prefer to focus on the combination of Sovaldi plus its own NS5A inhibitor ledipasvir, which was submitted for approval as a fixed-dose combination in the US earlier this month. BMS believes the labels for Sovaldi and daclatasvir in Europe should allow them to be used together.
Either way, the prospects of regimens based on oral drugs that could eradicate hepatitis C without interferon alpha therapy – which requires injections, has significant side effects and cannot be used in around 50 per cent of all hepatitis C cases – has led to multibillion dollar sales predictions for the cocktails that eventually lead the market.
Backing up that view, Sovaldi exploded onto the market at the tail end of 2013, racking up an impressive $136m in US sales – three times analyst expectations – despite only being available on the US market for less than a month. Its eye-watering $1,000-a-day price and pent-up demand for new oral therapies certainly helped early take-up, but the performance encouraged analysts to hike peak sales forecasts to $5b-plus.
Since the start of the year Sovaldi has also been approved in the EU, with launches in the UK, Germany and France by the start of February.