Bristol-Myers Squibb's Daklinza Gets EU Nod

Bristol-Myers Squibb says it will soon start marketing its hepatitis C drug Daklinza in the European Union, following its approval last week.

Daklinza (daclatasvir) is indicated for use in conjunction with other therapies, such as Gilead Sciences’ blockbuster drug Sovaldi (sofosbuvir).

Daklinza, when used in combination with sofosbuvir, provided cure rates of up to 100% in clinical trials, including patients with advanced liver disease, genotype 3 and those who have previously failed treatment with protease inhibitors, BMS said.

Treatment periods will range from 12 to 48 weeks, depending on patients’ genotypes and whether or not they have cirrhosis. Most will have shorter treatment periods than they would have on interferon and ribavirin, BMS said.

The drug recently won Japanese approval in combination with Sunvepra (asunaprevir). The drug is now under priority review by the FDA, and a decision is expected by the end of November. The FDA granted the drug breakthrough therapy status as a dual therapy alongside Sunvepra. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.