ERYTECH’S PUBLIC POLICY – EXPANDED ACCESS PROGRAM FOR INVESTIGATIONAL PRODUCTS
This policy sets out the general principles of Erytech’s expanded access program. It is intended as global guidance, although Erytech will act in strict accordance with all local country laws and regulations.
Erytech is a science-led organization researching and developing new medicines utilizing its ERYCAPS® platform. The company is currently operating in the United States and Europe, and none of the company’s products have received marketing approval in any country.
Erytech is currently conducting late-stage clinical trials for its lead product, eryaspase, to generate necessary safety and efficacy information in order to obtain regulatory approvals and to make eryaspase available for the broader patient population. More details about Erytech’s clinical trials with its lead compound, eryaspase, can be found on clinicaltrials.gov or by sending an email to: firstname.lastname@example.org
Erytech may support expanded access to eryaspase for qualified patients in USA and Europe, as permitted by the applicable local laws. Expanded Access may be provided in the following ways:
- Erytech may provide expanded access to eryaspase for patients with immediate life-threatening diseases in United States and Europe via an investigational application, provided the request for expanded access is made by a licensed physician and the patient’s situation meets the criteria listed below.
- Erytech may also provide expanded access to its investigational agent, eryaspase, via a formal protocol in the United States. A protocol providing access to patients with acute lymphoblastic leukemia (ALL) who developed hypersensitivity reactions to other asparaginase formulations and are unable to access other options is planned to start by the end of 2021.
Criteria for expanded access
- Requests for expanded access must be made by physicians.
- Patients are suffering from a life-threatening cancer.
- There are no satisfactory alternative treatments.
- There is sufficient evidence of safety and effectiveness in the indication.
- Investigational product is under active clinical development in the indication(s), where the expanded access is requested.
- Expanded access is supported via a regulatory mechanism in the respective country or region.
The use of eryaspase in formal programs will only take place in countries where Erytech intends to seek regulatory approval. This limitation will not apply for expanded access.
Process for requesting expanded access
To investigate further options for the appropriate access to Erytech’s medicines, any physician can contact Erytech by sending an email to: email@example.com
Erytech will acknowledge receipt of an expanded access request submitted by a physician within 48 hours. Expanded access requests are carefully reviewed and approved by Erytech’s Chief Medical Officer and are final. All physicians who receive our investigational product, eryaspase, via expanded access must comply with the local laws and regulations as well as the contractual conditions. In particular, all physicians must comply with aspects related to safety reporting.
Patients interested in accessing an Erytech medicine for compassionate use should talk to their physician.
Erytech is committed to transparency in its interactions with physicians and health care organizations/institutions in order to be consistent with applicable laws and/or codes of practice to the pharmaceutical industry. Erytech will fulfil all regulatory requirements to make information about our expanded access activities available to the public.