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
To participate in a clinical study, you or your child must meet certain eligibility criteria. These criteria identify similar disease characteristics which can allow researchers to better evaluate the investigational therapy. You should discuss participation in a clinical study with your physician who knows your medical history and current status and can help to determine whether you may be able to join a clinical study.
- Visit clinicaltrials.gov and search registered clinical studies for the disease.
- If you locate a clinical study with a participating site that you are interested in, you or your physician 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 Patients/Caregivers/Patient Advocates
Requests for early access to investigational therapies must be made by a qualified physician. You and your family should discuss your situation with your treating physician, including current status, available treatment options, and reason for considering treatment with an investigational therapy. Your physician should make the request for early access on your behalf. It is important that early access requests are made by medically trained personnel in order to avoid delays.
For more information on Early Access programs you may visit the US Food and Drug Administration website.
If you are a healthcare provider, click here.