Humanigen is Accepting Compassionate Use Enquiries for Lenzilumab
Compassionate use is intended to provide access to investigational medicines for patients with serious or life-threatening conditions who have limited available treatment options and are unable to participate in ongoing clinical trials.
Key Criteria for Consideration:
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Hospitalized with COVID-19 pneumonia
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Subject is not on IMV or progressing towards IMV
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Subject has SpO2<94% on room air or requires oxygen supplementation (low- or high-flow or NPPV)
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Subject has CRP levels less than 150 mg/L (biomarker for immune-mediated hyperinflammation)
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Subject is not pregnant and for females of child-bearing age that are not pregnant, will take adequate contraception
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Subject is not eligible to participate in any ongoing trials with lenzilumab and other therapeutic modalities have proven ineffective, are inappropriate or are unavailable at time of request
Requests for compassionate use must be initiated by a treating physician, so if you are a patient or caregiver, please ask your physician for support in this process.
Physicians should send compassionate use requests for lenzilumab to LenzilumabSTAT@humanigen.com.
Humanigen will acknowledge receipt of the individual compassionate use request by either phone or email in <24 hours.
All individual patient compassionate use requests submitted for lenzilumab must be for the treatment of hospitalized COVID-19 patients and will be evaluated carefully, fairly and on a case-by-case manner.
The following information should be included in the request:
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Date of request
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Requesting physician’s name, contact information (phone and email), address, and professional designation (e.g. MD)
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Shipping address for lenzilumab vials
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Confirmation that the patient is not eligible or able to participate in any ongoing clinical trials with lenzilumab and therapeutic alternatives have proven ineffective or are unavailable at the time of the request
Administration of compassionate use treatment must be in accordance with applicable laws, in accordance with FDA guidelines and requirements