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FDA Requests Data on Daclatasvir in Combination with Other Agents

The FDA issued a complete response letter to Bristol-Myers Squibb in response to its new drug application for daclatasvir, an NS5A complex inhibitor.

The FDA is requesting additional data for the drug’s treatment of hepatitis C virus in combination with other antiviral agents, as the original new drug application focused on a daclatasvir-asunaprevir combination. Bristol-Myers Squibb withdrew the new drug application for asunaprevir, an NS3/4A protease inhibitor, in October.

“Despite the recent advances in the treatment of hepatitis C, there remain significant areas of unmet high need in this disease area,” Francis Cuss, executive vice president and chief scientific officer of research and development at Bristol-Myers Squibb, said in a statement from the manufacturer. “Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the United States as quickly as possible.”

At The Liver Meeting in Boston, results from ALLY 3 showed that a daclatasvir-sofosbuvir (Sovaldi, Gilead) combination was associated with a 12-week sustained virologic response rate of 90% in previously untreated patients. UNITY 2 results, also presented at the meeting, showed that the combination of daclatasvir, asunaprevir and beclabuvir (Bristol-Myers Squibb) was associated with SVR12 rates of about 90% in treatment-naive and treatment-experienced patients.

The FDA issued a complete response letter to Bristol-Myers Squibb in response to its new drug application for daclatasvir, an NS5A complex inhibitor.

The FDA is requesting additional data for the drug’s treatment of hepatitis C virus in combination with other antiviral agents, as the original new drug application focused on a daclatasvir-asunaprevir combination. Bristol-Myers Squibb withdrew the new drug application for asunaprevir, an NS3/4A protease inhibitor, in October.

“Despite the recent advances in the treatment of hepatitis C, there remain significant areas of unmet high need in this disease area,” Francis Cuss, executive vice president and chief scientific officer of research and development at Bristol-Myers Squibb, said in a statement from the manufacturer. “Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the United States as quickly as possible.”

At The Liver Meeting in Boston, results from ALLY 3 showed that a daclatasvir-sofosbuvir (Sovaldi, Gilead) combination was associated with a 12-week sustained virologic response rate of 90% in previously untreated patients. UNITY 2 results, also presented at the meeting, showed that the combination of daclatasvir, asunaprevir and beclabuvir (Bristol-Myers Squibb) was associated with SVR12 rates of about 90% in treatment-naive and treatment-experienced patients.