The European Medicines Agency (EMA) has validated Bristol-Myers Squibb‘s (BMS) marketing authorisation application (MAA) for the use of NS5A replication complex inhibitor ‘daclatasvir’ (DCV) for treatment of adults with chronic hepatitis C (HCV) with compensated liver disease.
The application supports the use of daclatasvir in combination with other agents, including sofosbuvir for treatment of HCV patients with compensated liver disease such as genotypes 1, 2, 3 and 4.
The submission also includes the EU’s first all-oral and ribavirin-free investigational regimen – for use in treatment-naïve genotype 1, 2, 3 patients and protease inhibitor treatment failures.
When used in combination with other agents, DCV has the potential to address a high unmet need in the EU, where an estimated nine million people are living with hepatitis C.
Bristol-Myers Squibb senior vice-president of global development and medical affairs, research and development Brian Daniels said the company’s clinical trial programme has showed that daclatasvir has potential use as a foundational agent for multiple HCV treatment regimens.
"If daclatasvir is approved, we would focus on helping to ensure its availability to patients with limited treatment options and would work with EU health authorities to ensure access is achieved as quickly as possible," Daniels said.
The EMA submission is supported by results from several studies of daclatasvir with other HCV therapies and so far, it has been studied in more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care.
As well as showing pan-genotypic potency in vitro, daclatasvir has shown a low drug-drug interaction profile, supporting its potential for use in multiple treatment regimens and in people with co-morbidities.
The company said that no clinically relevant safety signals have been observed so far in daclatasvir clinical trials, and it has been generally well-tolerated in all investigational regimens and patient types.
The EU submission follows the recent BMS regulatory filing in Japan seeking approval of a DCV-based regimen for the treatment of patients infected with HCV genotype 1b.
DCV has been extensively studied as a foundational agent for multiple direct-acting antiviral (DAA) based combination therapies. It is currently being studied in the ongoing Phase III UNITY Programme, where it is being evaluated as part of an all-oral 3DAA regimen with other Bristol-Myers Squibb investigational agents.
Image: The MAA validation marks the start of an accelerated regulatory review process for DCV. Photo: courtesy of freedigitalphotos.net.