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Investigational Medicines for Compassionate Use Requests

Investigational Medicines for Pre-Approval Access Requests (also known as Compassionate Use)

At Janssen, we are often asked how patients with serious diseases may potentially obtain medicines under development and not yet approved by government health authorities (investigational medicines). "Pre-approval access" is the term used by Janssen for any access to an investigational medicine prior to its approval. Other terms used to describe pre-approval access include "compassionate use", "named patient programs" or, "expanded access".

The preferred and primary pathway for access to Janssen's investigational medicines is to enroll in a clinical trial. Information about ongoing Janssen clinical trials can be found at Janssen Global Trial Finder. Additional information about ongoing clinical trials outside of Janssen can be found on these sites (please note this list may not be exhaustive): United States, European Union, United Kingdom, Australia/New Zealand, China, Japan, Brazil, and Africa.

If a clinical trial is not an option, a patient's treating physician may submit an individual request for pre-approval access for an investigational medicine. Janssen reviews each request and makes decisions by evaluating factors that include but are not limited to:

  • The patient has a serious or life-threatening disease or condition
  • The patient is not eligible or cannot participate in a clinical trial
  • No alternative therapies are available, or the patient’s disease has exhausted all available therapies
  • Potential benefits of the investigational treatment outweigh the potential risks
  • Country/Territory laws and regulations
  • Availability of medication supply

Please note that only treating physicians may submit a request but that does not guarantee that access will be granted.

The investigational medicines in the table below are currently potential options for eligible patients. Treating physicians who wish to submit a request may do so by registering on the Janssen Managed Access Portal (MacWeb). Janssen commits to providing an answer within 5-10 business days, assuming all required medical information has been submitted.

The table below is updated monthly, is up to date as of November 1, 2022 and is subject to change.

Product

Country/Territory

amivantamab Mexico, United Arab Emirates
bedaquiline South Africa
bosentan Guatemala, Venezuela
darunavir South Africa, Uganda
erdafitinib Austria, Belgium, Cyprus, Denmark, Estonia, Finland, France, Greece, Ireland, Italy, South Korea, Lithuania, Mexico, Netherlands, New Caledonia, Norway, Philippines, Portugal, Réunion, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom
miglustat Singapore, Ukraine
niraparib France
niraparib/abiraterone acetate Belgium, Estonia, Israel, Switzerland, United States
rilpivirine long acting South Korea, Portugal, Spain
talquetamab Austria, Denmark, Finland, Greece, Israel, Italy, Netherlands, Spain, Sweden, Switzerland, United States
teclistamab Egypt, Estonia, Ireland, Romania, Saudi Arabia, United Arab Emirates, United Kingdom

Additional information about country specific processes for requesting investigational medicines may be found here.

For more information about the medicines listed above or any other Janssen medicine, please contact Janssen Medical Information via:

In the United States, please call 1-800-JANSSEN or email: [email protected].

Outside of the United States, please contact your Janssen local country office via our Contact Us page.

DISCLAIMER: This information is intended solely for informational purposes. It is not intended as medical or healthcare advice, or to be used for medical diagnosis or treatment for any individual problem. Always seek the advice of your doctor regarding any medical condition, and before changing your current treatment or starting any new treatment. The accuracy and completeness of the information herein is true and correct at the date of publication.

Compassionate Use & Pre-Approval Access

Compassionate Use & Pre-Approval Access

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