BMS Gets EU Approval for Hepatitis C Drug Daklinza

Bristol-Myers Squibb (BMS) reports that the European Commission has approved Daklinza (daclatasvir) for treating chronic hepatitis C virus (HCV) infection. Daklinza is a pan-genotypic NS5A replication complex inhibitor (in vitro), and it was approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for treating HCV infection in adults.

Daklinza was recently approved in Japan in combination with BMS’s Sunvepra (asunaprevir), a NS3/4A protease inhibitor. The Daklinza+Sunvepra Dual Regimen is Japan's first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis, according to BMS.

Applications for the daclatasvir Dual Regimen are also under review by the US Food and Drug Administration (FDA), which granted priority review status and set a target review date under the Prescription Drug User Fee Act (PDUFA) of November 30, 2014.

In 2014, the FDA granted BMS’ investigational daclatasvir Dual Regimen (daclatasvir + asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV infection. In 2013, Bristol-Myers Squibb's investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation in the US, which helped to expedite the start of the ongoing Phase III clinical testing. Additional studies with daclatasvir in combination with sofosbuvir, the active ingredient in Gilead Sciences’ Sovaldi, are being conducted in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients and patients with genotype 3 as part of an ongoing Phase III clinical testing.

Oral drugs to treat hepatitis C are an important target of new drug development. Gilead Sciences’ Sovaldi, which was approved by the FDA in December 2013, has had strong market success, posting first half 2014 sales of $5.75 billion. Sovalid is a once-daily oral nucleotide analog polymerase inhibitor for treating chronic hepatitis C  as a component of a combination antiviral treatment regimen. Gilead is also developing a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir  and sofosbuvir  with and without ribavirin for the treatment of genotype 1 chronic HCV infection. Gilead plans to submit a new drug application for the ledipasvir/sofosbuvir  fixed-dose combination with the Japanese Pharmaceutical and Medical Devices Agency by the end of 2014. The product is currently under regulatory review in the United States and European Union.

AbbVie is developing an all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis HCV infection. The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir co-formulated with ombitasvir (ABT-267) and dasabuvir (ABT-333) with or without ribavirin. The combination of three different mechanisms of action interrupts the HCV replication process with the goal of optimizing sustained virologic response rates across different patient populations. The drug is under accelerated assessment by the European Medicines Agency and priority review by the FDA. The company expects US commercialization in 2014 and European approval in early 2015.

Source: Bristol-Myers Squibb

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