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FDA approves expanded label of Daklinza for additional HCV patients
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Bristol-Myers Squibb Company announced the FDA approved an expansion of the Daklinza drug label for use in combination with Sovaldi to treat patients with hepatitis C virus infection genotypes 1 and 3, HIV-1 co-infection, advanced cirrhosis and post-liver transplant recurrence of the infection.
These label changes are indicative of clinical data from the ALLY-1 and ALLY-2 clinical trials, according to the release. Daklinza (daclatasvir, Bristol-Myers Squibb) is already approved by the FDA for use in combination with Sovaldi (sofosbuvir, Gilead Sciences) for adults with HCV genotype 3. The recommended dosage of daclatasvir is 60 mg in combination with sofosbuvir with or without ribavirin for 12 weeks.
“The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV,” Chris Boerner, head of U.S. Commercial, Bristol-Myers Squibb, said in the release. “HCV/HIV–co-infected patients and patients with advanced cirrhosis or post-transplant recurrence of HCV still pose a treatment challenge to physicians. … We have sought to make new treatment options available for these and other targeted populations that have not yet been able to fully benefit from currently available next-generation medicines.”
The release further stated that daclatasvir is “contraindicated in combination with medicinal products that strongly induce CYP3A and P-glycoprotein transporter,” due to a potentially lower exposure to daclatasvir and possibly lower efficacy.
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 granted Bristol-Myers Squibb priority review for three new drug applications for these difficult-to-treat patient populations in October 2015. The European Commission approved label changes for daclatasvir in January.
Disclosure: Boerner is employed by Bristol-Myers Squibb.