FDA Continues Clinical Hold on Investigational Hepatitis C Drug

The hepatitis C virus (HCV) drug candidate RG-101 is still on clinical hold by the FDA, according to Investopedia.

Regulus Therapeutics Inc’s HCV drug was placed on clinical hold in June 2016, due to a second case of jaundice reported during clinical trials.

Despite the drug manufacturer submitting a response following the hold, the FDA has requested final safety and efficacy data from an ongoing clinical trial. However, Regulus will be unable to present the data until the fourth quarter, because it will be unavailable until after 48 weeks of follow-up, Investopedia reported.

Internal server error