The US Food and Drug Administration will undertake a speedy review of three supplemental marketing applications for Bristol-Myers Squibb’s hepatitis C drug Daklinza, which, if successful, could significantly expand the drug’s scope in difficult-to-treat subpopulations.
The supplemental New Drug Applications are seeking approval for Daklinza in combination with sofosbuvir with or without ribavirin to treat chronic HCV patients with decompensated cirrhosis, post-liver transplant recurrence of HCV, or co-infection with HIV-1.
“Hepatitis C is not a one-size-fits-all, monolithic disease,” noted Douglas Manion, head of Specialty Development at BMS. “Our focus for the Daklinza-sofosbuvir regimen centers on addressing the needs of HCV patient subpopulations who need new options even in light of the extraordinary advances that have occurred in HCV treatment”.
The drug, an NS5A complex inhibitor, was initially approved in the US in July 2015 for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection.