By webmin on
Email
AbbviePAA@abbvie.com
NCT Name
NCT03123029; NCT05982873; NCT04278235
Acknowledgement
1 business day
EA Page
https://www.abbvie.com/who-we-are/access-to-investigational-drugs-policy.html
Sponsor
AbbVie
EA Therapies for Single Patient

ABBV-400

Advanced histologically or cytologically confirmed solid tumors characterized by MET amplification

Elezanumab

Acute spinal cord injury

Venetoclax

  • Chronic Lymphocytic Leukemia (CLL)
  • Multiple Myeloma
  • Acute Myeloid Leukemia (AML)
  • Non-Hodgkin's Lymphoma
  • Acute Lymphoblastic Leukemia (ALL)
  • Amyloidosis
  • Plasma Cell Leukemia

Upadacitinib oral solution

  • Ulcerative colitis
  • Crohn’s disease
  • Juvenile idiopathic arthritis (including sJIA, pJIA or JPsA)
  • Atopic dermatitis
EA Policies for Single Patient

ABBV-400

This program is designed to provide access to ABBV-400 prior to approval by the local regulatory agency. Availability will depend on the territory eligibility. A medical doctor must decide whether the patient might potentially benefit from receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Criteria:

  • The patient suffers from a serious or life-threatening illness or condition
  • There are no other suitable treatment options
  • The patient does not qualify for ongoing clinical trials

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05982873?term=C24-738&rank=1

Elezanumab

This program is designed to provide access to Elezanumab prior to approval by the local regulatory agency. Availability will depend on the territory eligibility. A medical doctor must decide whether the patient might potentially benefit from receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Criteria:

  • The patient suffers from a serious or life-threatening illness or condition
  • There are no other suitable treatment options
  • The patient does not qualify for ongoing clinical trials

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT04278235?term=C20-285&rank=1

Venetoclax

This program is designed to provide access to Venetoclax prior to approval by the local regulatory agency. Availability will depend on the territory eligibility. A medical doctor must decide whether the patient might potentially benefit from receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Criteria:

  • The patient suffers from a serious or life-threatening illness or condition
  • There are no other suitable treatment options
  • The patient does not qualify for ongoing clinical trials

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT03123029?term=C19-920&rank=1

Upadacitinib oral solution

This program is designed to provide access to Upadacitinib oral solution prior to approval by the local regulatory agency. Availability will depend on the territory eligibility. A medical doctor must decide whether the patient might potentially benefit from receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Criteria:

  • The patient suffers from a serious or life-threatening illness or condition
  • There are no other suitable treatment options
  • The patient does not qualify for ongoing clinical trials
COVID-19 Information

We have initiated a Phase 2 study of IMBRUVICA (ibrutinib) in patients with COVID-19 infection. The goal of this study is to determine whether IMBRUVICA is able to improve patient outcomes by diminishing the immune response known as the cytokine storm that contributes to the morbidity and mortality in COVID-19.  See: Study of Oral Ibrutinib Capsules to Assess Respiratory Failure in Adult Participants With CoronaVirus Induced Disease 2019 (COVID-19) and Pulmonary Distress

Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial (CATCO)

https://clinicaltrials.gov/ct2/show/NCT04330690?term=abbvie&recrs=acdfk&cond=COVID&draw=2&rank=1

AbbVie Partnering with Global Authorities to Determine Efficacy of HIV Drug in Treating COVID-19

Unconfirmed media reports from China claim Kaletra/Aluvia (lopinavir/ritonavir) is effective in COVID-19 treatment.
- AbbVie does not have access to Chinese clinical information and therefore cannot confirm its accuracy
- AbbVie donated Aluvia to the Chinese government for experimental use against COVID-19
- AbbVie is working with global health authorities to determine the efficacy and safety of lopinavir/ritonavir against COVID-19

Expanded Access Listings

Expanded Access to Telisotuzumab Vedotin

Conditions
Non-small Cell Lung Cancer (NSCLC)

This is an expanded access program (EAP) for eligible participants. This program isdesigned to provide access to Telisotuzumab vedotin prior to approval by the localregulatory agency. Availability will depend on territory eligibility. A medical doctormust decide whether the potential benefit outweighs the risk of receiving aninvestigational therapy based on the individual patient's medical history and programeligibility criteria.