Life Molecular Imaging

Expanded Access

Program

Requirements and applying
Request EA/CU
Contact information

Expanded Access & Compasionate Use of LMI investigational Products

LMI is dedicated to developing innovative diagnostic imaging solutions for patients with serious or life-threatening conditions. We recognize that there may be situations where patients with no alternative diagnostic options may seek access to our investigational products outside of clinical trials. This webpage outlines our approach to Expanded Access (EA) and Compassionate Use (CU) for products under investigation at LMI.

Expanded Access Program

Basic requirements
and applying

To review details on the basic requirements for qualifying and applying for Expanded Access/Compassionate Use (EA/CU), select each header below.

  • Review and fill out the EAP request form: click here.
  • For requests or questions, email Medical Affairs at expaccess@life-mi.com. Requests are acknowledged within 5 business days; follow-up inquiries within 2 business days.
What is EA/CU?
  • A pathway for patients unable to join LMI clinical trials to access investigational products.
  • Applies to LMI diagnostic PET imaging products not yet approved for patient use or any purpose.
  • May also apply between the period of regulatory approval and commercial availability.
Who is this for?
  • Intended to support healthcare professionals (HCPs) requesting access to investigational products for their patients.
Patient Eligibility

Patients must have:

  • A serious or immediately life-threatening condition.
  • Unsuccessful or inconclusive standard diagnostic tests with no alternatives.
  • Ineligibility for any LMI-sponsored clinical trials.
  • Sufficient evidence that benefits outweigh risks.
  • Adequate dosing information for their specific need.
Product Criteria

The investigational product must be:

  • Under investigation by LMI in one or more clinical studies.
  • Expected to have an acceptable safety profile.
  • Available to patients without affecting overall clinical development of the product.
HCP Responsibilities

HCPs must:

  • Be licensed and qualified. Submit a current CV and investigator information (may not apply to all countries).
  • Obtain regulatory/ethics approvals and patient consent, and comply with legal, regulatory, and LMI requirements.
  • Provide patient medical history, diagnosis, and justification for use of investigational product.
  • Provide procedure details upon request.
 
Additional HCP Information
  • If appropriate in the country requesting access, approved HCPs will receive the treatment protocol and informed consent form (ICF). Only applicable if not requesting an individual patient IND.
  • A Letter of Authorization (LOA) can be requested for individual patient IND submissions.
  • LMI will provide the investigational product upon request approval and meeting of all specifications.
  • Granting of EA/CU depends on health authority review.
Charging Policy
  • There may be a charge to cover direct manufacturing costs including shipping of product, protocol monitoring, reporting, and administrative expenses.
  • Cost discussions will begin after EA/CU is granted.
Important Limitations
  • No access is guaranteed.
  • Supply may be limited.
  • LMI can terminate access at any time, especially if safety/efficacy concerns arise.
  • This program does not apply to marketed products approved for PET imaging of β-amyloid plaques for Alzheimer’s disease (AD), including Neuraceq®.
  • This policy may not be applicable in some territories where LMI has provided third parties with permission to run expanded access programs.
Expanded Access Program

Request EA/CU & Contact Information

  • Review and fill out the EAP request form: click here.
  • For requests or questions, email Medical Affairs at expaccess@life-mi.com. Requests are acknowledged within 5 business days; follow-up inquiries within 2 business days.
  • Updates on status of regulatory review and approval are available upon request.
  • LMI may request additional information from healthcare professionals (HCPs).

For the detailed EA/CU policy, please click here.

Life Molecular Imaging

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ACTIVE PRODUCTION SITES WORLD WIDE
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Major drug development trials using Neuraceq®
Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to Neuraceq administration, please read the full Prescribing Information for additional Important Safety Information.

SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

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