The 21st Century Cures Act, enacted in 2016, requires manufacturers of investigational drugs intended to treat serious diseases or conditions to make publicly available their policy for evaluating and responding to expanded access requests for such products. Expanded access, also referred to as compassionate use, is a mechanism for enabling the use of an investigational therapy for an individual patient outside of a clinical trial, when the primary purpose of the investigational drug is to diagnose, prevent, or treat a serious disease or condition in patients and when no comparable or satisfactory alternative therapy options are available. This is in contrast to clinical trials, where more comprehensive safety and efficacy data are generally collected.
At Amneal, we fully understand and endorse the importance of Expanded Access Programs (EAPs) in certain circumstances. Treating physicians and patients should note that investigational drugs have not established safety and efficacy and have not yet been approved by the FDA for their specific use(s). It is important to carefully evaluate all potential risks and benefits before seeking expanded access to investigational drugs.
Considering the unique nature of the indication and limited target population for KSHN014, Amneal’s expanded access policy for KSHN014 is that the company will not be providing investigational product to U.S. patients. Accordingly, KSHN014 is not available via an EAP.
For additional information, contact Amneal at drugsafety@amneal.com.
Amneal may revise this policy at any time. Should expanded access become appropriate in the future, this web page will be updated accordingly, and information on how to apply for expanded access will be provided.