Access to Leronlimab Policy
As an unapproved drug, leronlimab is not available to the general public. However, certain patients who are facing serious illnesses, and who have exhausted all available treatment options, may be able to receive early access to investigational drugs that haven’t yet been approved by government regulatory agencies. The FDA allows for two options for treating patients with an unapproved drug, biologic or test article outside of a clinical trial. One option is “Expanded Access.” The other option is “Right to Try.”
It is important that you first consult with your healthcare provider before inquiring about potential access to leronlimab. Your healthcare provider can then use the contact information below to submit access request(s) to the Company.
For inquiries relating to CytoDyn’s currently active Expanded Access Program (EAP) for patients with triple-negative breast cancer (TNBC): CytoDynEAP@wepclinical.com
For all other (eIND) requests: dai@cytodyn.com
For the most up-to-date information regarding The Right to Try Act, and/or potential access for patients who have been diagnosed with life-threatening diseases or conditions, have tried all approved treatment options, and are unable to participate in a clinical trial to access certain investigational treatment options, please visit FDA.gov and review its overview regarding “Right to Try” allowances. https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try
WARNING: Leronlimab has not received regulatory approval from the FDA. The potential risks and benefits are not known. Doctors and patients should consider all possible benefits and risks before applying for expanded access (or right to try) to leronlimab.