Bristol-Myers Squibb’s hep C drug granted Breakthrough Therapy Designation

Bristol-Myers Squibb has announced the US Food and Drug Administration (FDA) has granted its new daclatasvir and asunaprevir medicine Breakthrough Therapy Designation.

The investigational DCV Dual Regimen is designed to treat genotype 1b chronic hepatitis C infection (HCV) and the FDA looked at data from the company's phase III clinical trial programme.

Breakthrough Therapy Designation is intended to speed up the review of drugs that can have an effect on serious or life-threatening conditions. Pharma companies that want the status must show preliminary clinical evidence of substantial improvement in regard to one clinically significant endpoint over drugs that are already available.

This is the second time the FDA has granted Breakthrough Therapy Designation to a daclatasvir-based regimen and Brian Daniels, senior vice-president of global development and medical affairs at Bristol-Myers Squibb, said this shows the drug's potential to "address the high unmet needs of the HCV patient population".

Approximately 170 million patients worldwide are infected with hepatitis C.