European Commission Approves Daclatasvir Across Multiple Genotypes
In late August, Bristol-Myers Squibb announced that the European Commission approved daclatasvir for use in combination with other therapies across genotypes 1, 2, 3 and 4 for the treatment of adults with chronic hepatitis C virus infection.
Daclatasvir (Daklinza) is the first NS5A complex inhibitor approved in the European Union available for use in combination with other therapies. The recommended treatment duration is 12 or 24 weeks, according to a company press release.
“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,” Michael P. Manns, MD, professor and chairman, department of gastroenterology, hepatology and endocrinology, Hannover Medical School, Germany, stated in the release.
The approval was supported by data from multiple studies. The safety of the drug has been demonstrated in diverse patient populations that include elderly patients, patients with advanced liver disease, post-liver transplant recipients and patients coinfected with HIV. No unique safety concerns have been identified in patients who were treated with daclatasvir across clinical studies and in the early access program. Several of these studies are ongoing, according to the release.
Daclatasvir was recently approved in Japan in combination with the NS3/4A protease inhibitor asunaprevir (Sunpreva). Applications for the daclatasvir dual regimen are also under review by the FDA, which granted priority review status and set a target review date under the Prescription Drug User Free Act of Nov. 30, according to the release.