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Regulatory Approval Sought for HCV Combo Treatment

Daclatasvir + asunaprevir targets genotype 1b infection

New drug applications (NDAs) have been submitted to the FDA for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor (Bristol-Myers Squibb). The data submitted in the NDAs support the use of DCV + ASV in patients with genotype 1b hepatitis C virus(HCV) infection.

The DCV NDA also seeks approval for the use of this compound in combination with other agents for multiple genotypes.

The new submissions follow the recent announcement that the FDA had granted the investigational DCV + ASV dual regimen a “breakthrough therapy” designation. In 2013, the investigational all-oral 3DAA regimen (DCV/ASV/BMS-791325) also received a “breakthrough therapy” regimen, and Bristol-Myers Squibb anticipates submitting this regimen for FDA review in the first quarter of 2015.

DCV is currently being studied in the ongoing phase III UNITY program, in which it is being investigated as part of the 3DAA regimen. Study populations include non-cirrhotic naïve, cirrhotic naïve, and previously treated patients with HCV infection. The 3DAA regimen is being studied as a fixed-dose combination treatment with twice-daily dosing.

DCV is also being investigated in combination with sofosbuvir in patients with a high unmet need, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing phase III ALLY program.

Source: Bristol-Myers Squibb; April 7, 2014.

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