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Access to Investigational Therapies
A licensed treating physician may submit an unsolicited request for Pre-Approval Access (PAA) to an argenx medicine for a patient with a life-threatening or seriously debilitating illness, if it cannot be treated satisfactorily with any currently authorized medicine. argenx is committed to evaluating all requests in a fair and equitable manner and in accordance with all local laws and regulations.
Criteria for Requests
Pre-Approval Access Principles
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Licensed Physician |
A properly licensed treating physician requests the use of an argenx unapproved product to treat a patient who is seriously ill, has no alternative treatment options, and cannot enroll in a clinical trial. |
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Active Development |
The requested product is in active clinical development and has sufficient scientific evidence to demonstrate that the benefits outweigh the risks in the context of the disease or condition being treated. |
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Treatment Alignment |
The patient profile and requested treatment regimens are aligned with those from current registrational studies. |
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No Commercial Interest |
The request is neither tied to a commercial interest nor associated with any promotional activities. |
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No Trial Interference |
Providing the medicine for the requested use will not interfere with the initiation, conduct, or completion of clinical trials. |
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Long-Term Supply Intent |
argenx will only consider a PAA request in a country where there is a bona fide intent for long-term supply after PAA. |
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Regulatory Compliance |
If approved, argenx will provide the medicine and adhere to all local laws and regulations. |
Pre-Approval Access Request
To request PAA, the licensed physician must submit a request to PAATeam@argenx.com.
Requests for treatment will be acknowledged and reviewed expeditiously by the argenx Medical Team. If a request for PAA is approved by argenx, the physician may also need to obtain Health Authority approval in that country prior to access to the investigational therapy.
Submission of a request does not guarantee access to investigational medicinal products (IMP).
In accordance with global laws, including the US 21st Century Cures Act, argenx may revise the posted PAA principles at any time.
Clinical Trials Information
Information about argenx clinical trials can be found here or on clinicaltrials.gov.
Ongoing argenx PAA Programs
Ongoing argenx PAA programs are listed at https://reaganudall.org/.
General Inquiries
General inquiries about PAA may be made to PAATeam@argenx.com. argenx is committed to responding promptly to all inquiries received about PAA; inquiries will be addressed within five business days.
Explore More
At argenx, every piece of the innovation story connects. See where it leads next.
Clinical Trials
Discover argenx-sponsored clinical trials currently underway.
Post-Trial Access
Read about the criteria for submitting a post-trial access request.
Clinical Research Guide
Realizing why someone would choose to participate can help you make your own decision.
