At Helsinn, we’ve made it our mission to improve the everyday lives of patients. We do this by developing and bringing to market a range of cancer therapeutics and cancer supportive care products.
Helsinn is aware that patients with serious or life-threatening disease or condition may seek urgently access to therapeutic options which are not available yet in their country or which may not have marketing approval yet. For this reason, under specific circumstances and in agreement with local health regulations, Helsinn may grant access to those medicinal products before marketing approval, these situations are referred to as Early Access Programs (EAPs) at Helsinn.
EAPs allow pre-approval, ethical, compliant and controlled access to investigational drugs outside clinical trials and prior to product launch to patients with life-threatening and serious debilitating diseases having no other treatment options available. Helsinn takes EAP requests into great consideration and is open to allow access to its drugs in selected countries, on condition that:
Different types of EAPs exist:
The EAP request form shall be completed by a physician. Please, note that only requests from verified physicians may be taken into consideration, therefore, if you are a patient, please contact your treating physician who will be responsible for completing the EAP request form. Subsequently, we will acknowledge receipt of the request within 7 business days and once all required information is collected, we will carefully review the request through a dedicated internal review committee, and we will aim to providing a response promptly.
EAPs are intended for patients with a life-threatening or serious debilitating disease, who have exhausted all alternative treatment options and who cannot participate in clinical trials due to not meeting entry criteria or their geographic location. The potential patient benefit shall justify the potential risks of the new medicine and there shall be clear biological rationale set forth to believe that the patient will benefit from treatment.