Avalyn Pharma Inc is committed to developing promising new therapies to address the unmet medical needs of patients suffering from rare lung diseases by conducting rigorous clinical trials and obtaining marketing approval from the US Food and Drug Administration (FDA) and other global 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 to find out about enrolling.
Avalyn Pharma Inc will consider providing our investigational medicines to patients, through their physician, if enrollment in a clinical trial is not possible and there is no similar or satisfactory alternative therapy to treat the disease or condition. In these situations, Avalyn Pharma Inc will consider providing pre-approval access to our investigational medicines once clinical trial experience has completed at least one year of administration and when certain conditions are met. These conditions are as follows:
- The patient to be treated has a severe or immediately life-threatening illness, and there is no satisfactory alternative therapy.
- The patient has undergone appropriate treatments (standard of care) and is no longer achieving benefit from treatment, and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.
- The patient must meet any other pertinent medical criteria for access to the investigational or unlicensed product, as established by Avalyn Pharma Inc’s clinical team.
- The patient is not eligible for or cannot access any ongoing clinical trials.
- The potential benefit of the investigational medicine to the patient outweighs the potential risk. This criterion should be evaluated by a patient’s physician and discussed in detail with the patient.
- There is an adequate supply of the investigational medicine, meaning the sponsor has a surplus of investigational drug over and above what is required for the ongoing clinical trials.
- Providing the investigational drug will not interfere with or delay clinical trials that could support a medical product’s development or marketing approval and, ultimately, availability to appropriate patients.
Requests for our investigational medicines must come from a patient’s treating physician. The requesting physician must be willing to obtain the appropriate regulatory and ethics committee approvals. The physician must also comply with various regulatory obligations, including obtaining patient consent, patient monitoring, safety, and outcome reporting as required by law and / or Avalyn Pharma.
Avalyn Pharma is committed to providing a fair and equitable evaluation of all the requests we receive. We will review submissions on a case-by-case basis, and the fact that our treatment is made available to one patient does not guarantee it will be made available to future patients. We continually evaluate the benefit-risk profile of our investigational drugs, and based on evolving clinical data, we may require additional information from a treating physician to fully evaluate a request. We cannot guarantee that all requests for access will be granted, even when eligibility criteria are met.
Physicians who want pre-approval access to an Avalyn Pharma investigational medicine should submit their requests to email@example.com. We regularly monitor this mailbox; and acknowledge each submitted request within 7 days after receipt.