Medical Access to Investigational Medicines (also known as Expanded Access or Early Access)

As an organization, Daiichi Sankyo’s mission is to create new standards of care and provide our medicines to patients who need them. Each medicine must undergo well-designed and well-conducted clinical trials to evaluate its efficacy and safety, demonstrating that its potential benefits outweigh its known risks to patients before it can become available by prescription.
Obtaining regulatory approval for marketing is the most efficient and rapid way to provide access to new medicines to the greatest number of patients who may benefit. Therefore, Daiichi Sankyo believes its resources should be directed toward sponsoring clinical trials that support the regulatory approval of an unapproved investigational medicine, or of a new indication for an already approved medicine, thereby offering the greatest benefit to at-risk patient populations.
We recognize, however, that there are instances when a patient has a serious or life-threatening disease or condition, for which:

• treatment options are not available or have been exhausted,
• enrollment into a clinical trial is not possible or justifiable, and
• adequate supply of the investigational medicine is available to address the patient’s need.

In these cases, a treating physician may request access to the use of a Daiichi Sankyo investigational medicine prior to regulatory approval for a particular condition or indication, provided it is permitted by applicable local laws.
Daiichi Sankyo may be able to arrange provision of an investigational medicine through a Medical Access program (sometimes referred to as “expanded access,” “compassionate use,” or “early access”).  Granting access to an investigational medicine through a Medical Access program should not delay, interfere with, or compromise the completion of clinical trials that are intended to support approval by regulatory authorities.
Daiichi Sankyo strives for an equitable balance between the public interest in securing the approval of a new medicine and allowing access to certain investigational medicines that may have the potential to treat seriously ill patients who cannot be satisfactorily treated with commercially available therapies.
For an overview of our investigational medicines, please visit our pipeline chart. Alternatively, you may visit www.clinicaltrials.gov and search for information on clinical trials sponsored by Daiichi Sankyo.

Who might be eligible for expanded access to a Daiichi Sankyo investigational product?

The following criteria are typically required before Daiichi Sankyo would consider patients eligible for early Medical Access to an investigational Daiichi Sankyo investigational medicine. All criteria are subject to local laws and regulations.

• The patient suffers from a life-threatening or serious disease or condition where there is an unmet medical need that cannot be met by existing therapeutic options.
• The patient is ineligible or unable to participate in any ongoing clinical study of the investigational medicine.
• The investigational medicine is under active development (a dose and regimen has been defined and the investigational medicine is typically in Phase 2 development or beyond) and has not been placed on regulatory or any other hold.
• The benefit-risk profile of the drug in the potential indication and the patient population is deemed, to date, to be positive. This typically occurs when Daiichi Sankyo has decided to seek marketing approval in at least one major market globally.
• Daiichi Sankyo has the intent to seek marketing approval in at least one major market globally.
• The use of the investigational medicine through the Medical Access program will not jeopardize the development of the investigational medicine (for instance, granting access to an investigational medicine through expanded access should not delay, interfere with, or compromise the completion of clinical trials that are intended to support approval by regulatory authorities).
• The use of the investigational medicine in a protocol for the Medical Access program is compliant with local rules and regulations.

Daiichi Sankyo cannot approve a request for to an investigational medicine through a Medical Access program in cases when doing so would violate company policy, local laws or regulations, or if access may present an unacceptable benefit/risk profile, as determined by medical personnel of the company.

Our Commitment

We commit to a careful and fair evaluation of each request by the appropriate medical experts at Daiichi Sankyo in accordance with local laws and regulations. All requests for Medical Access (which must be made by the treating physician) will be acknowledged by medical personnel from Daiichi Sankyo (or our agent) within five (5) business days. Should the request be granted, the requestor must enter into an agreement with Daiichi Sankyo.

For approved requests

• The investigational medicine will be provided in accordance with local laws and regulations.
• The requestor must report any safety issues that may be associated with the use of the investigational medicine to Daiichi Sankyo and regulatory authorities as required.
• The treating physician, and not Daiichi Sankyo, is responsible for securing local ethics committee approval for use of its investigational medicine under a Medical Access program.

Important Considerations

Daiichi Sankyo is diligently working to bring our medicines to patients as soon as possible and is committed to ensuring that once a patient has started on the investigational medicine, they are guaranteed continuous supply until they/their physician deems it is time to stop treatment.

Maintaining a safe demand-supply balance of any medicine is very delicate.  Daiichi Sankyo continually monitors its supply of its investigational medicines.  When possible, based on availability of supply, we may have the ability to allocate limited quantities on a case-by-case basis.  This is based on a variety of factors such as ensuring the allocation does not delay, interfere with, or compromise the completion of ongoing or anticipated clinical trials or study cohorts that are intended to support approval by regulatory authorities. This approach is intended to ultimately provide access to the medication for the greatest number of individuals.

Making a Request

Only the treating physician may submit requests for investigational medicines for a patient under a Medical Access program; Daiichi Sankyo cannot consider requests directly from a caregiver or a patient.  The treating physician requesting access should follow the instructions below:

Click here to access the form for requesting Medical Access to Daiichi Sankyo investigational medicines. Physicians requesting access to Daiichi Sankyo investigational medicines should fill out and submit the form. Daiichi Sankyo medical personnel, or our agent, will review the form for completeness, make a decision on the request, and notify the requestor of the decision.

If a decision is made to provide access to a Daiichi Sankyo investigational medicine, the requestor will be notified by Daiichi Sankyo as soon as possible with instructions for executing the agreement. Upon full execution of the agreement, drug shipment coordination with the physician’s office will be scheduled.

For information on ongoing clinical trials please refer to https://clinicaltrials.gov/.

As always, patients are our priority; please do not hesitate to contact us if you require additional information via expandedaccess@dsi.com.