General
Expanded Access Programs (EAPs), including Compassionate Use (CU), are a regulatory pathway that allows biopharmaceutical companies to provide investigational drugs, which have not been FDA-approved, to patients with a serious or immediately life-threatening illness when there are no comparable or satisfactory alternative treatments available, and the patient is ineligible or unable to participate in a clinical trial.

Preference for Clinical Trials
Use of an investigational drug within a clinical trial is generally preferable, where possible, because clinical trials follow protocols to both monitor and safeguard patient experiences with a drug, and generate data that may lead to the approval of therapies. It is important that any EAP does not interfere with the completion of clinical trials or otherwise compromise the potential development of the investigational drug. Once the FDA approves a drug, EAP/CU are no longer available. 

Risks and Requirements of EAP/CU
Participation in an EAP/CU is not without risks, and a doctor must determine whether the potential benefits outweigh the risk of receiving an investigational drug, based on an individual patient’s medical history and circumstances. Also, EAP/CU requires the review and approval of an Institutional Review Board/Ethics Committee to at a treating location to review and approve the use of the drug before it can be provided.  

Alumis Expanded Access Policy
Currently, production of our investigational drugs is limited to accommodate participants in clinical trials and therefore, Alumis does not offer expanded access. Our resources are focused on conducting clinical trials and generating safety and efficacy data. Patients may speak with their doctors to determine if they should explore participation in clinical trials.  

EAP Request Procedure
As we are not currently accepting expanded access requests for our investigational drug, we do not have a procedure for making an expanded access request or contact information for such requests. Alumis may review and update this policy over time as more clinical data becomes available. 

Contact Information
If you have questions about our investigational drugs, clinical trials, or expanded access policy, please contact Alumis at MedAffairs@Alumis.com.  

Additional Information
For more information on the clinical trials of Alumis, search “Alumis” or “ACELYRIN” at clinicaltrials.gov. Additional information on expended access is available from the US Food and Drug Administration website at: Expanded Access | FDA