LeafBio has an expanded access program for the investigational product, ZMapp. Through the program, ZMapp is being made available for use in eligible patients with documented Ebola Virus Disease demonstrated by a positive Ebola Virus RT-PCR test, or a well-documented high-risk Ebola Virus exposure. ZMapp is an investigational medicine, and has 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 ZMapp.
Physicians seeking expanded access to ZMapp for a patient should submit their request to email@example.com. Additional information about ZMapp can be found by going to www.clinicaltrials.gov and searching NCT02363322.
In addition, please see the following information regarding expanded access to ZMapp:
What is ZMapp?
ZMapp is a cocktail of three monoclonal antibodies directed against the Zaire strain of Ebola virus. This strain was responsible for the EVD outbreak in West Africa (2014 – 2016).
What is an Expanded Access Program?
An expanded access program is a U.S. regulatory mechanism for making an unlicensed drug 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?
Physicians seeking access to ZMapp for eligible patients should submit their requests to firstname.lastname@example.org. LeafBio regularly monitors this mailbox and will typically acknowledge inquiries for patients with PCR confirmed Ebola Virus Disease or documented high-risk exposure to Ebola Virus within 24 hours of receipt.
Individual patients seeking access should work with their physician to understand the potential benefits and risks of ZMapp and determine if they might be eligible. Requests must be submitted by a physician.
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?
LeafBio will determine if the patient meets eligibility requirements, and if sufficient product is available for the patient. Other specific criteria for expanded access apply, in accordance with FDA regulations (e.g., there must not be other viable options for treatment, including approved products or active clinical trials).
What are the eligibility requirements?
To be eligible for expanded access to ZMapp, participants must meet certain requirements, including, but not limited to:
- Documented Ebola Virus Disease, demonstrated by a positive Ebola Virus RT-PCR test within the last 10 days
- Well-documented high-risk Ebola Virus exposure, defined as any of the following:
- Direct contact with bodily fluids from a confirmed Ebola Virus case
- Needle stick injury with a potentially Ebola Virus contaminated needle
- Prolonged exposure to an Ebola Virus infected person without personal protective equipment
Note: ZMapp should be used for confirmed or suspected cases of the Ebola Zaire strain, and is not effective against other Ebola strains.
Can everyone who meets the eligibility requirements receive ZMapp?
Patients meeting the eligibility requirements for expanded access may be candidates to receive ZMapp, but LeafBio cannot guarantee access to ZMapp. While LeaBio intends to ensure there is sufficient drug supply for qualifying patients, LeafBio cannot guarantee drug supply. For this and potentially other reasons that are currently unforeseeable, LeafBio reserves the right to restrict access at any time. LeafBio also reserves the right to update this policy at any time.
Do patients who receive ZMapp under expanded access have to pay for ZMapp?
When ZMapp is provided to a patient under expanded access, LeafBio makes ZMapp available free of charge. LeafBio is not responsible for other financial aspects of patient care.
Contact information for LeafBio:
6160 Lusk Blvd., # C200
San Diego, CA 92121