Expanded Access
An investigational medicine is one that is undergoing testing but has not yet been approved for use by regulatory authorities such as the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Before a medicinal product can be made available for patients, it must undergo several phases of evaluation through clinical trials to prove that the medicine is safe and effective, and its potential benefit to patients outweighs the possible risks.
At Avalyn, we are committed to developing promising investigational medicines to address the unmet medical needs of patients suffering from rare lung diseases by conducting rigorous clinical trials and obtaining approval from regulatory authorities.
Our goal is to provide access to our medicines at the appropriate time and in a manner most beneficial to the relevant patient population. Enrollment in our ongoing clinical trials is the safest and most effective way of achieving this goal, and we encourage all patients and physicians to visit the clinical trial section of our website. Given the phase of development, we are not providing access to our investigational medicines through any other mechanisms.
If you think there is a trial that is suitable for you, or someone you are caring for, the first step is to talk to your doctor.
Learn more about our ongoing clinical trials.
