RedHill Biopharma Limited

“RedHill’s Expanded Access Policy Access to Investigational New Drugs Intended to Treat Serious, and/or Life-threatening Diseases For new medicines to be legally approved for use, companies are required to evaluate their safety and effectiveness in clinical trials and submit results to regulatory agencies that will ultimately decide whether the potential benefits outweigh the potential risk. As such, to protect patients, RedHill Biopharma usually restricts access to our investigational new drugs to patients participating in clinical trials. Expanded access, or compassionate use, is an individual patient use of an investigational new drug outside of a clinical trial. Expanded access is sometimes possible when the investigational new drug is needed to treat a serious or life-threatening condition and there is some clinical evidence suggesting that it might be effective in that condition. This page explains RedHill’s policy and the options that may be available to patients in these circumstances.”

Complete response (i.e. disappearance of all target lesions and all non-target lesions) reported in U.S. patient with advanced gallbladder carcinoma treated with YELIVA® as part of RedHill’s Expanded Access Program, allowing compassionate use for eligible patients.

Conditions: Cholangiocarcinoma, Cholangiocarcinoma Non-resectable, Cholangiocarcinoma, Perihilar, Cholangiocarcinoma, Extrahepatic, Cholangiocarcinoma, Intrahepatic