Expanded Access Program for Leronlimab
At CytoDyn, we understand that sometimes people may seek access to investigational medicines before they approved by a regulatory authority, such as the U.S. Food and Drug Administration (FDA). This can be done in two ways - through clinical trials or expanded access.
Our goal, whenever possible, is to encourage patients to participate in clinical trials. Clinical trials are research studies designed to determine if an investigational medicine is safe and effective for patients. Data generated by these studies provide regulatory authorities with essential information needed to evaluate the safety and the effectiveness of a new medicine. And only after reviewing this information the regulators may approve a new medicine, allowing it to be widely available to patients.
In rare cases, however, when people don't qualify for clinical trials and have exhausted all available medical options, CytoDyn may consider providing an investigational medicine outside of a clinical trial. This is called expanded access.
Types of Access to Investigational Medicines
For new medicines and vaccines to be legally approved for use, companies like CytoDyn are required to evaluate their safety and effectiveness in clinical trials and submit trial results to regulatory agencies. To participate in a trial, you must meet certain criteria. For those who meet the criteria to join a clinical trial, participation offers the chance to contribute to medical research that may benefit many others. Participation in a clinical trial comes with certain risks; that is why "informed consent" is a required step in the process of enrolling.
To learn more about available clinical trials visit clinicaltrials.gov and search by company, disease or medicine, or here for CytoDyn HIV clinical trials, or for CytoDyn's clinical trial for triple-negative breast cancer here.
Expanded access, also known as compassionate use, may be an option for a limited number of individuals with serious or life-threatening conditions, who have exhausted all available medical options and do not qualify for clinical trials.
For more information from the FDA about expanded access in the U.S., click here.
CytoDyn Approach to Expanded Access
Making decisions about expanded access requests is always complex. We at CytoDyn strive to make these decisions as comprehensively as possible, considering the patient's case and the available medical and scientific information about the investigational medicine. Our primary responsibility is to ensure that expanded access can be done in a manner that upholds the safety of patients and ethical principles, such as fairness, promoting good and minimizing the risk of harm for both current and future patients.
CytoDyn will consider granting Individual Patient expanded access to an investigational medicine only if all of the following threshold criteria are met:
- The patient has a serious or life-threatening illness with no comparable or satisfactory alternative therapies.
- The patient is ineligible for, or otherwise unable to, participate in a clinical trial.
- The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational medicine and the benefit outweighs the known or anticipated risks.
- The investigational medicine is currently in clinical development - that is, it is currently being studied in humans.
- Providing the investigational medicine for the requested use will not interfere with the initiation, conduct, or completion of clinical trials.
- Once a regulatory agency approves a medicine for commercial use, existing expanded access programs will be phased out.
Requesting Expanded Access
Individual patient expanded access is managed by the patient's physician. We encourage patients to speak first with their physician about their eligibility to enroll in a clinical trial.
If a treating physician believes expanded access may be the only option for a patient, the physician should contact CytoDyn to make a formal request on behalf of the patient. This will enable the physician to work with CytoDyn's physicians to determine the best course of action.
The request for access to a CytoDyn investigational medicine can only be considered if the patient's treating physician is committed to, and supportive of, the requested treatment.
In the U.S., physicians seeking help on behalf of their patients may contact CytoDyn here. Once CytoDyn has received the request and required medical information, we will respond in no more than five business days. If the request is approved by CytoDyn, the country regulatory authority from where the request originated will need to grant final approval before CytoDyn can ship the investigational medicine to the requesting physician.
Alternatively, physicians may utilize the request form below to provide contact information to CytoDyn. Once this form has been submitted, it will be routed to the appropriate contact at CytoDyn, who will then communicate with the requesting physician within five business days.