& Compassionate Use
Expanded Access & Compassionate Use
We are committed to delivering innovative therapies to patients with serious diseases.
Clinical trials are a critical component of this effort, and they help to determine whether a new therapy is safe and effective. Until regulatory authorities make the decision whether to approve a new therapy for a specific disease, it remains experimental and is generally not available to patients with that disease or condition outside of the clinical trials. If you would like to learn more about our clinical programs, visit Clinical Trials or www.clinicaltrials.gov.
We understand that there are critically ill patients who will not meet all of the criteria to enroll in our clinical trials and don’t have options for alternative therapies. In these circumstances, we will consider allowing access to the investigational therapy through an Expanded Access Program. An Expanded Access Program is for a group of patients who have the same disease being evaluated in our clinical trials that we plan to submit to regulatory authorities in support of approval of the therapy.
In order to be eligible, patients need to meet the following criteria:
- Suffer from a serious or immediately life-threatening disease or condition.
- Have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.
- Are ineligible for participation in any ongoing clinical study of the investigational therapy, which includes lack of access due to geographic limitations.
- The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational therapy and the benefit outweighs the known or anticipated risks.
- There is adequate information to support appropriate dosing for special population patients such as pediatric, elderly, renal or hepatic disease, etc.
- Any other pertinent medical criteria for access to the investigational therapy, as established by Hoth.
It’s important to remember that investigational therapies have not yet received regulatory approval; therefore, their potential risks and benefits are not yet established. Doctors and patients should consider all possible benefits and risks when seeking expanded access to an investigational therapy.
A treating physician may submit questions or requests regarding expanded access to email@example.com. For a copy of our full Expanded Access Policy and eligibility criteria, click here.
A Message From Our CEO
Founded on the belief that biotech companies must go beyond drug development and marketing – we hold a commitment to the patients and their families to deliver therapeutics that address patient needs.