Early Access Programs
At AMPL, 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.
AMPL 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, AMPL may grant access to those medicinal products before marketing approval, these situations are referred to as Early Access Programs (EAPs) at AMPL.
What are EAPs ?
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. AMPL takes EAP requests into great consideration and is open to allow access to its drugs in selected countries, on condition that:
- the EAP request concerns a drug which applies to EAP criteria outlined by local regulations;
- the concerned drug is not marketed in the country of origin of the EAP request;
- provision of the investigational product will not interfere with ongoing clinical trial(s) or overall development program.
Different types of EAPs exist:
- Groups of Patients, also known as Cohort Programs, Compassionate Use Programs (CUP), or Treatment Protocols (in USA), may be initiated by the pharmaceutical company to make a medicinal product available to a group of patients in a selected clinic, hospital or in a selected country for patients with a serious debilitating disease, or patients whose disease is considered to be life-threatening and who cannot be treated satisfactorily by an authorized medicinal product.
- Individual Patients, also known as Named Patient Program (NPP) or Single Patient Expanded Access, can be granted by local regulatory bodies in response to requests by physicians for a specific patient with an unmet medical need that cannot be treated satisfactorily by an authorized medicinal product.