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.
For information on ongoing clinical studies:
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 email@example.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:
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.
All requests for early access for a single patient or patients must be submitted by the patient’s treating physician.
Qualified physicians can submit a request by contacting Avalo at firstname.lastname@example.org.
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:
Avalo is committed to supporting expanded use, when possible.