Sobi may make an investigational medicine available if the following eligibility criteria and additional requirements are met:
§ The patient has a serious or life-threatening disease without a satisfactory alternative therapy or treatment and an unsolicited Managed Access request has been submitted to Sobi by the treating physician
§ The patient is not eligible or able to enter an ongoing clinical trial
§ There is sufficient data to indicate that the benefit of the investigational medicine outweighs the potential risks in the context of the disease or condition being treated
§ There is a sufficient supply of the investigational medicine available and providing the medicine will not interfere with ongoing clinical studies or other development activities
§ The patient meets any eligibility criteria set by Sobi’s Medical Committee evaluating Managed Access requests
§ Laws and regulations in the country of request allow Managed Access
Email
ClinicalTrials.gov URL
EA Policies for Single Patient