Access to Investigational Therapies
Avalo Therapeutics’ goal is to provide potentially life-saving therapies to patients who may benefit from them, while minimizing potential risk. Avalo believes that clinical trials are the most effective way for patients to access investigational products, as clinical trials can generate data that may lead to the approval of new medicines and wider availability to patients. However, in certain situations, Avalo will assess requests for access to unapproved products, via an Expanded Access program.
Expanded Access (or Compassionate Use) is a process that may help qualified patients obtain investigational therapies that are not yet approved by the country’s regulatory agencies (e.g., the Food and Drug Administration [FDA]) outside of a clinical study when there is a compelling need.
Please note that prior to submitting a request for Expanded Access to a therapy, patients, caregivers, and treating physicians should make every effort to identify and attempt to enroll in a clinical study, as appropriate. Information regarding Avalo-sponsored clinical trials may be found at www.clinicaltrials.gov.
Clinical Study Information
For information on ongoing clinical studies:
- Visit ClinicalTrials.gov and search registered clinical studies for the disease. To search by company (Avalo Therapeutics), click here.
- If you locate a clinical study with a participating site that you are interested in, you may contact that site directly for more information.
- For a list of ongoing Avalo Therapeutics clinical studies, contact the Avalo Therapeutics Patient Advocacy group at patientadvocacy@avalotx.com.
Early Access
At Avalo, we recognize that some patients with serious or immediately life-threatening diseases may not be able or eligible to participate in clinical studies and may not have other treatment options for their condition. Avalo carefully evaluates requests for individual patients to receive investigational therapies outside of a clinical study on a case-by-case basis.
Avalo recognizes that patients with serious or life-threatening diseases may seek medical products that are not yet approved or available in their country. The company has established the following Expanded Access policy to guide patients, their families, and treating physicians who seek to be considered for such access.
Avalo will consider requests from licensed treating physicians for access to investigational products in development for patient treatment purposes on a case-by-case basis.
Treating physicians interested in potential access to investigational products may request more information by contacting Avalo via email at expandedaccess@avalotx.com. Please note that only requests submitted by treating physicians will be considered.
Receipt of a request for information will be acknowledged within 10 business days.
Some of the factors that will be considered upon receiving a request include:
- Whether the patient has a serious or life-threatening illness
- Whether the patient has undergone standard treatment without success or there is no viable alternative therapy
- Whether the potential benefits of the experimental product will outweigh any potential risk to the patient
- Whether the patient is ineligible for or is unable to participate in a clinical trial for the investigational product
- The impact of providing access to an investigational product on the development program for that product
- The impact of providing access to an investigational product on the available inventory and supply for that product
Avalo’s decision on whether or not to grant expanded access to the investigational product under an Expanded Access Program should be communicated to the requestor within 15 business days of receipt.
Application under this policy is not a guarantee of access to any Avalo investigational drug. Avalo reserves the right to revise or revoke this policy at any time.
Additionally, Avalo reserves the right to deny any request at it’s discretion.
Decisions for expanded access will be made on a fair and equitable basis for each investigational therapy. Each disease we are studying may have different specific criteria due to the differences in urgency and known data on safety and efficacy.
For Physicians/Healthcare Professionals
All requests for early access for a single patient or patients must be submitted by the patient’s treating physician.
- The patient’s treating physician must provide adequate information to demonstrate that the patient meets the outlined considerations for early access.
- The patient’s treating physician must be appropriately licensed, fully qualified to administer the investigational therapy and have the expertise and facilities for monitoring, managing and reporting any adverse events during the course of treatment. The patient’s treating physician must be willing to meet and follow all applicable legal and regulatory requirements for early access while caring for the patient receiving investigational therapy and must comply with all applicable reporting requirements.
Qualified physicians can submit a request by contacting Avalo at expandedaccess@avalotx.com.
For more information on Expanded Access for Patients and Physicians you may visit the United States Food and Drug Administration website.
Avalo will review the request and supporting documents from a treating physician to determine the urgency and need of the request. We are committed to acknowledging receipt of a request within 10 business days. We aim to respond to the request, including our rationale, as promptly as possible so that your patients and their families can explore all possibilities.
When evaluating the request, we will consider the best option:
- First, we will determine if an appropriate Avalo-sponsored clinical study or an Investigator-initiated clinical study is regionally available.
- If no study is available, then we will consider early access outside of a clinical study:
- If the disease has been treated with the investigational therapy and shown to be safe and effective, we will respond promptly and provide guidance to the physician to ensure all applicable regulatory and legal requirements are met.
- If the disease or condition is one we have not treated or are not studying, our ability to help may be limited. In general, prior treatment of the disease with the investigational therapy is needed for Avalo to consider early access.
Avalo is committed to supporting expanded use, when possible.