Kyowa Kirin Co., Ltd.

Single-Patient EA Policies/Criteria Process for Requesting Expanded Access Kyowa Kirin seeks to fulfill its management philosophy of striving to contribute to the health and wellbeing of people around the world by creating new value through the pursuit of advances in life sciences and technologies. Physicians who are interested in treating a patient with a Kyowa Kirin unapproved drug and meet the criteria stated on our webpage must do the following:

1. Submit a request to Kyowa Kirin’s via email to the Access Mailbox: access@kyowakirin.com or via any Kyowa Kirin Medical Science Liaison with whom you have contact. The company will endeavor to acknowledge receipt of the request via email within five (5) business days of submission of the request.
2. Provide additional information as may be requested by Kyowa Kirin such as: relevant medical patient information, a persuasive scientific rationale for the theoretical benefit that the unapproved drug could provide to the patient, a statement no comparable or satisfactory alternative therapy options are available for the patient, including participation in ongoing relevant clinical trials. Making a request does not guarantee the granting of access to an unapproved drug. Kyowa Kirin will review each request on a case-by-case basis. The decision to grant access is solely Kyowa Kirin’s decision. Kyowa Kirin reserves the right to terminate the supply of drug at any time. Contact for Further Information and Link to ClinicalTrials.Gov Persons with questions about Kyowa Kirin’s policy for expanded access or about other issues related to expanded access to unapproved drugs may contact the company at the Access Mailbox: access@kyowakirin.com . Further information about Kyowa Kirin’s clinical trials in the U.S. is available on the NIH’s ClinicalTrials.gov website.