argenx

Single-Patient EA Policies/Criteria Pre-Approval Access Principles: a properly licensed treating physician requests the use of an argenx unapproved product to treat a patient that is seriously ill, has no alternative treatment options and cannot enroll in a clinical trial; the requested product should be in active clinical development, and it is being requested to treat an indication for which there is positive data from a pivotal or registrational study; there is sufficient scientific evidence to demonstrate that the benefits of the investigational medicine outweigh the risks; the patient profile and requested treatment regimens are aligned with those from current registrational studies; the request is neither tied to a commercial interest nor associated with any promotional activities; providing the IMP for the requested use will not interfere with the initiation, conduct, or completion of clinical trials; if approved, argenx will provide IMP and adhere to all local laws and regulations. Available Therapies via Single-Patient EA An Expanded Access Program for Efgartigimod Treatment in Patients With Generalized Myasthenia Gravis Brief Summary This expanded access protocol applies to patients with gMG who are not enrolled in an ongoing clinical trial. The aim of the trial is to provide patients with generalized myasthenia gravis (gMG), who are ineligible to participate in a clinical trial, access to efgartigimod treatment before regulatory approval. There are country-specific protocols and also individual use PAA. Recruitment for the treatment protocol in US is now closed (ARGX-113-EAP-2101) and in countries where reimbursement is obtained.