Patient Access to Investigational Therapies
argenx is committed to improving the lives of people suffering from rare diseases.
We’re driven to discover new treatment approaches in autoimmunity and cancer, and fueled by the resilience of patients to urgently deliver them.
We aim to do this in partnership; we listen to patients, supporters and advocacy communities, and we hear their stories. Their insights guide us as we develop our investigational therapies, and motivate us to advance the understanding of rare diseases.
We believe that participation in clinical trials is the most appropriate way for patients to access investigational therapies. Information about argenx clinical trials can be found here or on clinicaltrials.gov.
Kim, MG patient and advocate, businesswoman
and mother of 2 boys
We understand that participating in clinical trials may not always be possible for patients. In cases where a patient faces a life-threatening or serious condition, a clinical trial isn’t an option, and/or the patient has exhausted all available treatment options, a physician may be able to request access to an investigational medicine for a patient through pre-approval access. argenx will consider providing access to investigational medicines to patients through an argenx pre-approval access program when certain conditions are met.
Regulators/health authorities may grant permission for argenx to provide a treating physician with an investigational medicinal therapy. This is typically done through a pre-approval access program.
Any use of argenx investigational product outside a clinical trial in a country must be in accordance with local laws and regulations governing such programs, including argenx policies and procedures.
Information on the argenx pre-approval access policy can be found here.
If you are interested in participating in an argenx clinical trial and would like more information, or if you have any questions about this pre-approval access policy, please talk to your doctor or contact us. General inquiries about patient access may be made to [email protected]. argenx is committed to responding promptly to all inquiries received about pre-approval access; inquiries will be addressed within 5 business days.
Submission of a request for PAA does not guarantee access to investigational medicinal products (IMP).
In accordance with global laws, including the US 21st Century Cures Act, argenx may revise this posted pre-approval access policy at any time.