Bristol-Myers Squibb has launched Daklinza (daclatasvir) in the UK just days after the hepatitis C pill was granted European approval.
The drug has a European licence for use in combination with Gilead’s hugely successful Sovaldi (sofosbuvir) as an all-oral, once-daily regimen for the hepatitis C virus.
Charles Gore, chief executive of The Hepatitis C Trust, said: “With only 3% of people with hepatitis C in England accessing treatment each year, we are delighted by the announcement as it is crucial patients are able to access new treatments as early as possible so they have the opportunity to get cured of this cancer-causing virus.”
Daklinza is a first-in-class NS5A inhibitor that works across multiple genotypes as an oral once-daily treatment for the majority of patients with chronic hepatitis C.
One of its major benefits is that it does not need to be used with interferon alpha therapy, the current standard course of treatment that has possible side effects including depression, insomnia and flu-like symptoms.
Johanna Mercier, general manager of Bristol-Myers Squibb UK and Ireland, noted: “Study results have highlighted that daclatasvir has the potential to offer high cure rates, notably offering some of its most successful results in genotypes 1 and 3, which account for 90% of all hepatitis C cases in the UK.
In clinical trials, different daclatasvir-based combinations have shown promising cure rates for patients. Up to 98% of patients with genotype 1 and around 89% with genotype 3 showed positive clinical results when combining the pill with Sovaldi (sofosbuvir).
Data published in the NEJM earlier this year supporting the submission also included results from combining daclatasvir with interferon-alpha and ribavirin. After 12 weeks of treatment, 100% of patients with genotype 4 achieved sustained virologic response (SVR).
In January 2014, the European Medicines Agency (EMA) brought daclatasvir forward for priority review after recognising the need that exists for hepatitis C patients.
Daklinza forms the lynchpin of Bristol-Myers Squibb’s hepatitis C aspirations and its Sovaldi combination continues to be investigated as a treatment for patients with high unmet needs in hepatitis C.