FDA Not Lifting Clinical Trial Hold on Sovaprevir
Bloomberg reports that the U.S. Food and Drug Administration has announced that it would not be lifting the hold placed on Archillion Pharmacy’s hepatitis C drug Sovaprevir, believing that development of the drug should not resume.
Sovaprevir Placed on Hold
- The FDA originally placed Sovaprevir on hold in July after finding high levels of liver enzymes in otherwise healthy clinical trial patients.
- In the clinical trial patients were given Sovaprevir in combination with two HIV drugs to determine the risks and side effects that would result from combining the hepatitis C drug with other medications.
- The FDA became concerned as high liver enzyme levels are normally an indication of liver damage meaning both the clinical trial patients and future patients could have been exposed to renal injury.
Sovaprevir, Sofosbuvir, Daclatasvir and Hepatitis C Market
- Archillion currently has three drugs in clinical trials as it competes with other companies like Gilead and Bristol-Myers Squibb (BMS) to gain control over the hepatitis C drug market.
- It is estimated that 170 million people suffer from hepatitis C resulting in a potential $20 million market for a successful new treatment.
- While the combination of Gilead’s Sofosbuvir and BMS’s Daclatasvir showed extraordinary success in clinical trials, BMS is holding out for an entirely in-house solution despite increased risks of heart failure and death linked to its Daclatasvir/BMS-986094 attempt.
Contact an Experienced Drug Trial Injury Attorney
If you or a loved one participated in a Hepatitis C clinical trial and suffered injuries, contact Thomas J. Henry immediately for a free consultation. We are available 24/7 nights and weekends. Call 1-888-956-8000.