Gil Roth01.08.14
Bristol-Myers Squibb's MAA for the use of daclatasvir (DCV), an investigational NS5A complex inhibitor, for the treatment of adults with chronic hepatitis C (HCV) with compensated liver disease, including genotypes 1, 2, 3, and 4, has been validated by the EMA.
The application seeks the approval of daclatasvir for use in combination with other agents, including sofosbuvir, for the treatment of chronic hepatitis C. The MAA validation marks the start of an accelerated regulatory review process for DCV.
The EMA submission is supported by data from multiple studies of daclatasvir with other HCV therapies. To date, DCV 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. In addition to demonstrating pan-genotypic potency in vitro, DCV has shown a low drug-drug interaction profile, supporting its potential use in multiple treatment regimens and in people with co-morbidities. No clinically relevant safety signals have been observed thus far in DCV clinical trials, and DCV 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.
The application seeks the approval of daclatasvir for use in combination with other agents, including sofosbuvir, for the treatment of chronic hepatitis C. The MAA validation marks the start of an accelerated regulatory review process for DCV.
The EMA submission is supported by data from multiple studies of daclatasvir with other HCV therapies. To date, DCV 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. In addition to demonstrating pan-genotypic potency in vitro, DCV has shown a low drug-drug interaction profile, supporting its potential use in multiple treatment regimens and in people with co-morbidities. No clinically relevant safety signals have been observed thus far in DCV clinical trials, and DCV 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.