FDA grants priority review of Daklinza in difficult-to-treat patients

Bristol-Myers Squibb announced the FDA has accepted the company’s three supplemental New Drug Applications for review of Daklinza in combination with Sovaldi for the treatment of hepatitis C virus infection in the settings of cirrhosis, post-transplant and co-infection.

The new drug applications include review of Daklinza (daclatasvir, Bristol-Myers Squibb) in combination with Sovaldi (sofosbuvir, Gilead Sciences) with or without ribavirin to treat patients with HCV with decompensated cirrhosis, post-liver transplant recurrence of HCV and HCV/HIV-1 co-infection. The FDA will review the applications within 6 months and, if approved, it “would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions,” according to the release.

“Hepatitis C is not a one-size-fits-all, monolithic disease. 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,” Douglas Manion, MD, head of specialty development at Bristol-Myers Squibb, said in the release. “We look forward to working with the FDA toward the goal of eventually helping many difficult-to-treat HCV patients.”

According to the release, the new supplemental applications include clinical data from the ALLY-1 and ALLY-2 trials. ALLY-1 evaluated a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for patients with HCV with either advanced cirrhosis or post-liver transplant recurrence of HCV. ALLY-2 evaluated the once-daily 12-week combination of daclatasvir and sofosbuvir for patients with HCV/HIV-1 co-infection.

The FDA approved daclatasvir for the treatment of HCV genotype 3 infection in July, after clinical data showed 98% of the treatment-naive patients without cirrhosis and 58% of treatment-naive patients with cirrhosis achieved sustained virologic response with a combination regimen of daclatasvir and sofosbuvir.

In a previous press release, the FDA stated that daclatasvir carries a warning for patients and health care providers following reports of serious slowing of the heart rate and cases requiring pacemaker intervention. These events occurred when amiodarone was co-administered with sofosbuvir in combination with another HCV direct-acting antiviral, including daclatasvir.

Disclosures: Manion reports being employed by Bristol-Myers Squibb.