Information on the Expanded Access Policy for Mapp investigational products
Mapp Biopharmaceutical, Inc. (Mapp) investigational products may be made available for use in eligible patients with a documented disease or a well-documented high-risk exposure to a pathogen for which Mapp has available material. Mapp investigational products available under expanded access are investigational medicine and have not been licensed by the U.S. Food and Drug Administration (FDA) or other health authorities. Patients should work closely with their physician to understand the potential benefits and risks of an investigational product prior to use.
Physicians seeking expanded access to Mapp investigational products for a patient should submit their request to expandedaccess@mappbio.com.
In addition, please see the following information regarding expanded access to Mapp investigational products:
What is an Expanded Access Program?
Expanded access is a U.S. regulatory mechanism for making an unlicensed drug (investigational product) available for the treatment of a serious or life-threatening disease for which no approved therapeutic is available. Expanded access may be offered for individual patients, intermediate-size patient populations, or for widespread use. For more information, visit www.fda.gov.
How does the expanded access request process work at Mapp?
Physicians seeking access to a Mapp investigational product for eligible patients should submit their requests to expandedaccess@mappbio.com. Mapp regularly monitors this mailbox and will typically acknowledge inquiries for patients with the confirmed disease or documented high-risk exposure to a pathogen against which Mapp has an investigational product within 24 hours of receipt.
Individual patients seeking access should work with their physician to understand the potential benefits and risks of Mapp’s investigational products and determine if they might be eligible. Requests must be submitted by a physician.
What pathogens might Mapp have investigational products available for Expanded Access?
{The product development page} lists the programs for Mapp investigational products in development. Requests will be considered on a case-by-case basis. Availability of these investigational products may vary over time and their use under expanded access is subject to availability and may require concurrence from FDA regarding expanded access use.
What is the length of time anticipated to be necessary to acknowledge receipt of requests?
Requests made for patients with PCR confirmed Ebola Virus Disease or documented high-risk exposure to Ebola Virus typically will be acknowledged within 24 hours of receipt.
What are the general criteria used to evaluate and respond to requests by Mapp?
Requests made for patients with the confirmed disease or documented high-risk exposure to a pathogen for which Mapp has an investigational product typically will be acknowledged within 24 hours of receipt.
What are the eligibility requirements?
To be eligible for expanded access to a Mapp investigational product, participants must meet certain requirements, including, but not limited to:
- Documented disease or,
- Well-documented high-risk exposure to a pathogen, which may include but is not limited to: * Direct contact with bodily fluids from a confirmed pathogen case * Needle stick injury with a potentially pathogen contaminated needle * Prolonged exposure to a person infected with a pathogen without personal protective equipment
Can everyone who meets the eligibility requirements receive a Mapp investigational product?
Patients meeting the eligibility requirements for expanded access may be candidates to receive a Mapp investigational product, but Mapp cannot guarantee access to our investigational products. While Mapp intends to ensure there is sufficient drug supply for qualifying patients, Mapp cannot guarantee drug supply. For this and potentially other reasons that are currently unforeseeable, Mapp reserves the right to restrict access at any time. Mapp also reserves the right to update this policy at any time.
For investigational products without an existing Expanded Access Protocol in place, FDA concurrence regarding expanded access use may be required.
Do patients who receive a Mapp investigational product under expanded access have to pay for the investigational product?
When Mapp provides an investigational product to a patient under expanded access, Mapp makes the investigational product available free of charge. Mapp is not responsible for other financial aspects of patient care.
Contact information for Mapp Bio:
Mapp Biopharmaceutical, Inc. 4921 Directors Pl Suite 100 San Diego, CA 92121
Email: to expandedaccess@mappbio.com