Expanded Access Policy
Policy on Expanded Access to Investigational Medicines
Last updated: AUGUST 1, 2021
Allakos is a biotechnology company developing targeted therapies for inflammatory diseases.
To bring innovative medicines to patients in need, we need to conduct the research and clinical studies necessary to evaluate the safety and effectiveness of our investigational medicines. We believe that rigorous clinical studies are the most appropriate way to do this. We are committed to working closely with researchers, healthcare professionals, clinical trial site teams, patients and caregivers to enroll, conduct and analyze our studies. If successful, data from these studies may support submissions to the U.S. Food and Drug Administration (FDA) and other regulatory authorities for potential approval – with the ultimate goal of quickly making our medicines available to eligible patients.
At this time, we are not making our investigational medicine lirentelimab available on an expanded access basis to any new patients. Participation in one of our clinical studies is the only way to receive it. Our clinical studies use important safety and efficacy monitoring practices that both are designed to help protect patients and enable product development to proceed as quickly as possible, allowing for the widest possible distribution of our products to patients in need of treatment. This decision was made after careful evaluation of many factors, including: the fact that the safety and effectiveness of lirentelimab is still being evaluated in clinical trials, our manufacturing capacity and supply considerations, and what we believe is in the best interest of patients.
We understand there are currently no approved targeted treatments for eosinophilic gastritis and eosinophilic duodenitis (EG/EoD)—two of the diseases for which lirentelimab is being studied—which is why we are working hard to develop this medicine as quickly as we can. There are other clinical studies evaluating potential new therapies for these diseases. We recommend that you talk to your doctor about what is right for you.
If you are interested in participating in one of our clinical studies and would like more information, or if you have any questions about this expanded access policy, please talk to your doctor or contact us at 650-597-5002 (select option for Clinical Studies Information). We generally respond to expanded access questions or requests sent to us within seven business days of receipt.
More information about the company’s ongoing clinical studies can be found by visiting ClinicalTrials.gov.
Allakos will continue to evaluate the possibility of expanded access as we advance development of our investigational medicines. Allakos reserves the right to revise this expanded access policy at any time. The availability of this policy or any revised version does not serve as a guarantee of access to any of our investigational medicines by any individual patient.