Altesa’s Expanded Access Policy
In cases where a clinical trial is not an option, Altesa Biosciences, Inc. (“Altesa”) may elect to provide physician-requested expanded access to its investigational medicines in the U.S. and other countries where Altesa intends to submit an application for marketing authorization of the requested product. Treating physicians and patients should note that investigational medicines do not have established safety and efficacy, so all potential risks and benefits should be carefully evaluated before seeking expanded access to unapproved medicines.
Altesa will update this site and provide notification when investigational agents are available for use. At that time, Altesa will consider requests for access to its investigational medicines, as permitted by applicable law, in very specific circumstances, when all of the following criteria are met:
- The patient has a serious or immediately life-threatening disease for which no alternative therapies are currently available.
- The expanded access program is authorized for the requested indication.
- There is adequate clinical evidence of a positive benefit to risk profile for the investigational medicine in the disease indication, suggesting that a clinically meaningful benefit may be expected and that the benefits outweigh any potential risks.
- Providing investigational medicine through expanded access will not compromise clinical trials or the regulatory pathway.
- Patient is not eligible for participation in an open/ongoing Altesa therapeutic trial with the investigative agent (the patient’s location relative to a participating trial site is not considered as part of trial eligibility)
Once notification of investigational product availability is made, physicians seeking expanded access to a Altesa investigational product on behalf of their patients should submit an inquiry EAP@altesabio.com. Altesa will acknowledge receipt of requests from treating physicians, generally within 24 to 48 hours of receiving the request for information. Physicians will then be directed to submit required documentation to Altesa.
Professionals at Altesa who are familiar with the data collected on the investigational drug will evaluate the request based on the scientific evidence available at the time of the request. Altesa will strive to respond to the treating physician immediately after the receipt of required medical documentation. If Altesa supports the request for investigational medicine, final approval from regulatory bodies and execution of relevant agreements with Altesa will follow.
Physicians who receive a Altesa investigational medicine patients through the expanded access program must comply with all applicable laws and regulations, contractual conditions, safety reporting required by regulatory agencies, conditions of the Altesa agreement, including but not limited to protection of intellectual property.
This policy is subject to change. Altesa will revisit the policy periodically and amend it as appropriate.
Media/All Other Inquiries:
For general medical inquiries about our products not relating to access, including ongoing or planned clinical trials, please visit our website (altesabio.com) or clinicaltrials.gov.
For vendor inquiries or solicitations, please email firstname.lastname@example.org.