As described in our Position on Early Access and Post-Trial Access to Investigational Therapy, Astellas believes the safest and most effective way of providing access to our investigational therapies is through enrollment in our ongoing clinical trials. Astellas also recognizes the importance of utilizing the applicable regulatory and legal pathways for providing access to our investigational therapies when patients with life-threatening diseases have exhausted all available treatment options and are not eligible for clinical trials. For ongoing clinical trials sponsored by Astellas with investigational therapies currently in development, please visit https://clinicaltrials.gov/.
Astellas defines “early access” as the provision of an Astellas investigational therapy to patients outside of the clinical trial setting, upon receipt of an unsolicited request by a prescribing healthcare professional. Where permitted by local regulations, Astellas will consider unsolicited early access requests from physicians for patients with no viable therapeutic alternatives. Requests are considered on a case-by-case basis, although provision of early access cannot be guaranteed when requested.
For certain Astellas investigational therapies, usually those targeting life-threatening diseases for which there are no currently available therapeutic alternatives, Astellas may initiate an early access program to manage individual requests more efficiently. An early access program may operate in a number of countries utilizing various legal pathways to access, depending on local laws and regulations. As such, program requirements may vary by country. Early access programs begin before marketing authorization, and typically end no later than commercial availability.
Please see the link below for Astellas global early access programs which are currently planned, operating or enrolling patients. These are programs that provide patients with access to investigational therapies that are currently in development and require physicians to follow an approved treatment protocol. A link will be provided for early access programs that are registered on ClinicalTrials.gov. Please follow the link to confirm if the program remains open to new patients.
Astellas Early Access Programs
Healthcare Professional Requests
If you are a Healthcare Professional and would like to request early access for one of your patients, please e-mail Astellas at [email protected] or call 1-800-727-7003. Include the following information when contacting Astellas:
- The project code or compound name
- Name and contact number of the patient’s physician
Do not include any information that could identify the patient.
Physicians outside the US should contact their local Astellas office. A directory is available at:
https://www.astellas.com/worldwide/.
Patient Requests
- If you are a patient and would like to obtain early access to investigational therapy, please contact your Healthcare Professional.