Early Access to Investigational Therapy

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 serious and 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 serious, 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. Early access programs that require physicians to follow an approved treatment protocol are registered, if required by regulation, on ClinicalTrials.gov, the EU Clinical Trials Information System and/or local registries.

Healthcare Professional Requests

Healthcare professionals can submit early access requests for their patients using our Access to Medicines Request Platform. Our Access to Medicines Request Platform streamlines requests for support into one central and accessible location.

Click here for the Access to Medicines Request Platform.

Patient Requests

• If you are a patient and would like to obtain early access to investigational therapy, please contact your Healthcare Professional.