Regulatory Open Forum

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  • 1.  Expanded Access

    Posted 11-Feb-2019 12:56
    ​​Hello

    I have an interest in US Expanded Access Programs and have been looking for examples of EAPs for a new indication or for a new dose/dosage regimen of a drug already authorised by FDA in a different indication/dose/dosage regimen.

    Is anyone aware of any publicly documented precedents? And is EA possible at all in such circumstances?

    Thanks in advance for any thoughts or experience you may have,

    Marcello

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    Marcello
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  • 2.  RE: Expanded Access

    Posted 12-Feb-2019 08:56
    Hi Marcello,

    I am not aware of any specific examples, but I would see no reason that couldn't be possible. It would be unlikely that a manufacturer would provide product under expanded access for just a different indication if the product could be dosed with the marketed product. As a simple example, a 250 mg tablet was approved for once daily administration and a new indication required twice daily dosing. But, if an intravenous formulation was under development for the same or different indication, expanded access could be possible as long as the 3 conditions are met:

    (1) The patient or patients to be treated have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition;
    (2) The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated; and
    (3) Providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: Expanded Access

    Posted 19-Feb-2019 13:00
    Hi Marcello,
    Couldn't find product or program you interested in under the EAP program as the EAP program is for drugs/biologics/devices still undergoing clinical trials whose indications have not been cleared by the FDA. why not look into off-label use- approved drugs used for unapproved indications.

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    Sylvia Ukponmwan
    Covington GA
    United States
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    Original Message


  • 4.  RE: Expanded Access

    Posted 19-Feb-2019 13:35

    Marcelo,

    I can help answer part of your question" I​s anyone aware of any publicly documented precedents? And is EA possible at all in such circumstances?

    EAP is possible for already approved drugs for using different condition or population. For example, if the already approved drug use is restricted for adults only and physician wants to use in pediatric population (e.g AMPYRA). Such use if possible under EAP. Similarly if there is black box warning on the drug label, physician can request for EAP for using it for restricted conditions. I am not aware of any information available in public domain about lists of EAP granted and conditions it was used for.

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    Ashwani Khurana PhD RAC
    United States
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    Original Message


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