Expanded Access Program Main Content
Expanded Access Program
Daiichi Sankyo is committed to providing beneficial medicines to patients who need them. Through robust, thorough and swift clinical trial programs, we seek the necessary evidence for effectiveness and safety of our investigational products. Obtaining regulatory approval for marketing is the most efficient and rapid way to provide rapid access to new medicines to the greatest number of patients who may benefit.
Expanded Access Program may be an option to access investigational medicine for patients with serious diseases or conditions : (1) who are not able or are ineligible to participate in a Daiichi Sankyo clinical trial, and (2) where no other treatment option is available, and (3) when results from our clinical trials suggest that one of our investigational products may offer benefit.
The following criteria must be met before Daiichi Sankyo considers establishing an Expanded Access Program (EAP) for a Daiichi Sankyo investigational product:
- Patient suffers from a serious disease or condition, where there is an unmet medical need that cannot be met by existing products
- Patient is ineligible or unable to participate in any ongoing clinical study of the investigational product
- Investigational product is under active development (Phase 2 and beyond)
- The benefit-risk profile of the drug in the indication and the patient population is positive
- There are adequate supplies of investigational product to meet the needs of an EAP without impairing the clinical trial development program
- The expanded access use of the investigational product will not interfere with development of the drug
- There are plans to file and commercialize the drug in the region
- The use of the investigational product in an expanded access protocol is compliant with local rules and regulations
- There is a good understanding of the likely indication to be approved
- The use of the investigational product will discontinue as soon as practical when approval of the drug is achieved in the country
- The program will be equitably available to the population of the region in question
If you are a patient who feels that expanded access may benefit you, please consult with your physician. Your physician must complete and submit the Expanded Access Program request form.