Europe's CHMP recommends approval of Daklinza to treat hepatitis C
A positive opinion from the CHMP means the drug moves to the European Commission for final approval in the European Union, where an estimated nine million people live with hepatitis C-a virus that infects the liver and causes chronic infection in up to 90 percent of patients.
Research has been devoted to the creation of anti-viral drugs that inhibit key viral functions, thereby inhibiting disease progression. Daklinza-or daclatasvir-is a non-structural protein 5A (NS5A) inhibitor, which prevents viral replication, a critical step in the infection process.
"Through Bristol-Myers Squibb's Early Access Programs in Europe, more than 2000 HCV patients with advanced liver disease have already been treated with Daklinza in combination with sofosbuvir," Elliott Levy, the head of specialty development at Bristol-Myers Squibb, said. "We anticipate that, if approved, Daklinza-based regimens will play a significant role in treating HCV patients with high unmet medical needs across Europe."
Approval was granted for Daklinza, which was recently included in the European Association for the Study of the Liver's (EASL) clinical practice guidelines for the management of hepatits C infection, based on multiple studies of the drug.
During clinical trials patients were treated with a combination of Daklinza and sofosbuvir-or Sovaldi, an RNA polymerase inhibitor.
In 2012, Mark Sulkowski, the medical director of the Viral Hepatitis Center at Johns Hopkins University, presented the results of a 12-week trial that showed the use of a polymerase inhibitor and NS5A inhibitor, without interferon or ribavirin, produced sustained response rates for up to 100 percent of patients.
Bristol-Myers Squibb is awaiting a decision from Japanese drug authorities for a Daklinza-based trial. The U.S. Food and Drug Administration (FDA) has granted the clinical trials for the drug priority review status and will review the drug in November.