Access to Investigational Therapies for Patients in the United States

 

At F2G, we are developing medicines to treat serious fungal diseases, including where other therapies have failed. For information about our ongoing clinical trials, contact F2G at medinfo@f2g.com or visit https://www.clinicaltrials.gov/.

We recognize that in some patients with serious or life-threatening diseases or conditions may not be able to join a clinical trial and satisfactory alternative treatments may not exist. Our Managed Access Program (MAP), sometimes referred to as “compassionate use,” “pre-approval access,” or “expanded access”, is a potential pathway for these US patients to gain early access to our investigational therapy outside of clinical trials when no comparable or satisfactory alternative treatment options are available.

When seeking expanded access to an investigational therapy, the patient and their physician must consider all possible risks associated with that therapy. Investigational therapies have not been approved by the FDA, and these products have not yet been determined by the FDA to be safe and effective for their specific use.

Managed Access Program Criteria (US Patients)

F2G considers granting access to its investigational therapy when the following criteria are met:

  • The patient has a serious or life-threatening disease and there is no comparable or satisfactory alternative therapy available
  • The patient is not eligible or able to enroll in a clinical trial or continue participation in a trial
  • There is a potential patient benefit that justifies the potential risk of treatment use, and these risks are not unreasonable in the context of the disease or condition to be treated
  • The provision of the investigational therapy will not interfere with the initiation, conduct, or completion of an F2G clinical trial or overall development program
  • The treating physician has submitted an independent request on behalf of a patient

Information on the ongoing F2G Managed Access Program is available at https://clinicaltrials.gov/. The F2G Managed Access Program is intended for US patients only; for patients in other regions, please contact Shionogi B.V. at MAPteam@shionogi.eu.

Requesting Access

Requests for early access to our investigational therapy must be made by the patient’s treating physician. The physician must be willing to agree in writing to comply with F2G’s requirements related to patient confidentiality, medical criteria, adverse event/safety reporting, treatment monitoring, and certain requirements requiring the handling and use of the product. The physician must also agree to perform these duties on a continued basis while the patient is receiving the investigational therapy under the MAP.

Qualified physicians can submit a request by contacting F2G at Medinfo@f2g.com.

Evaluation and Response

F2G will acknowledge receipt of a request from the patient’s treating physician within three (3) working days and make every effort to respond within 24 hours.

We will then review requests on a fair and impartial basis, considering the availability of the investigational therapy supply and an assessment of the MAP criteria by medical experts. The decision to provide access will be based on the patient’s eligibility for access and the likelihood of the requested therapy meeting the patient’s unmet medical need. All decisions will be made in compliance with US laws and regulations.

Scroll to Top