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European Commission amends Daklinza label to include various patient populations

Bristol-Myers Squibb Company announced the European Commission has expanded the drug label of Daklinza and it is now approved for use in combination with Sovaldi to treat patients with hepatitis C virus infection genotypes 1 through 4, decompensated cirrhosis, HIV-1 co-infection 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 European Commission for use in combination with other medicinal products for adults with HCV genotypes 1, 2, 3 and 4 and is not recommended as a monotherapy, according to the release.

In addition, 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, the release said.

“The European Commission’s approval of these new indications for Daklinza is an important step forward for a significant group of patients with chronic hepatitis C who are still in need of treatment options that can deliver high cure rates,” Douglas Manion, MD, head of specialty development for Bristol-Myers Squibb, said in the release. “The complex clinical considerations for physicians treating HCV/HIV co-infected patients and patients with cirrhosis, decompensated cirrhosis or post-transplant recurrence of HCV reinforces the vast diversity of this disease, and we have worked hard to continue to identify and address those patients who require additional solutions for cure.”

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 National Institute for Health and Care Excellence also recommended daclatasvir for the treatment of HCV genotypes 1, 3 and 4 infection in England and Wales in 2015.

Disclosure: Manion is employed by Bristol-Myers Squibb.