Bristol-Myers Squibb (BMS) has secured EU approval for its new hepatitis C virus (HCV) drug Daklinza as part of a combination regimen with Gilead Sciences’ massively successful Sovaldi.
The European Commission cleared Daklinza (daclatasvir) for use alongside Sovaldi (sofosbuvir) as an all-oral, once-daily regimen for HCV that does away with the need for interferon injections.
For BMS, the label gives it an opportunity to ride the slipstream of Sovaldi’s rocket-like trajectory that has allowed it to become the most lucrative pharma launch of all time, racking up no less than $5.75bn in the first six months of 2014 despite only being launched at the end of last year.
Daklinza is the first drug in the NS5A replication complex inhibitor class to reach the market in Europe and has been approved on the back of data indicating it can cure 100% of patients when combined with Sovaldi in as little as 12 weeks, compared to 48 weeks for interferon-based therapies.
BMS’ drug has also been given a broad label; it can be used in the four main strains of hepatitis C (genotypes 1, 2, 3, and 4) as well as in patients with advanced liver disease and who have failed prior treatment with HCV protease inhibitors such as Merck & Co’s Victrelis (boceprevir) and Vertex’ Incivek (telaprevir).
Michael Manns of Hannover Medical School in Germany, who was one of the principal investigators in the Daklinza trials programme, said: “HCV is a challenging virus to overcome, requiring multiple modes of attack.
“With the approval of Daklinza, we have a new class of drug that disrupts the virus in two ways – by inhibiting both viral replication and assembly – and when combined with other compounds often results in cure among even the hardest-to-treat patients.”
While BMS will no doubt be celebrating, Gilead itself will be less joyous as it would prefer patients were prescribed its fixed-dose combination of NS5B polymerase inhibitor sofosbuvir and NS5A replication complex inhibitor ledipasvir, which is expected to be approved in the EU later this year and has an FDA review date of October 10.
Gilead declined to participate in the registration trials for the combination of sofosbuvir and daclatasvir.
In fact, an arms race is fast-developing in HCV with companies trying out multiple combinations to try to trim the treatment duration. For instance, a triple combination of sofosbuvir, ledipasvir and Gilead’s protease inhibitor GS 9451 achieved a 100 per cent cure rate after just six weeks in a National Institutes of Health (NIH) trial reported in March.
Meanwhile, in the US the FDA has granted priority review status for Daklinza-based treatment regimens, with a review date of November 30. It has also awarded breakthrough status to BMS’ drug in combination with its NS3 protease inhibitor Sunvepra (asunaprevir), a regimen that has already been approved in Japan as the country’s first interferon- and ribavirin-free HCV regimen.