Early Access to Investigational Therapies

At F2G, we are developing medicines to treat serious fungal diseases where other therapies have failed or are proven ineffective. To assess the safety and efficacy of our medicines, we are currently conducting clinical trials that will support the regulatory approval. A medicine can only be marketed and made available to patients after it has been authorised. We therefore are putting all our efforts to the efficient conduct of these trials. If you need more information about our ongoing clinical trials, contact F2G at medinfo@f2g.com or visit https://www.clinicaltrials.gov/

We recognize in some circumstances patients with serious or life-threatening diseases or conditions may not be able or eligible to join a clinical trial and satisfactory alternative treatment options may not exist.

Our early access program makes our investigational therapy available to qualified patients outside of a clinical trial despite the remaining pre-approval uncertainty about the full profile of the investigational therapy’s efficacy and safety. Our early access program (also known as “compassionate use” or “expanded access”) applies in cases where the medicine has not yet been approved in a certain country or if the patient needs to continue taking a medicinal product after their participation in a clinical trial has finished (also referred to as ‘post-trial access’)

Requests for this program are evaluated on a case-by-case basis. Patients interested in accessing a F2G medicine for treatment use should talk to their HCPs about their condition and discuss the options available for them.

Criteria for Consideration to access a medicine via the program

Our decision for early access is based on the following considerations:

  • Serious disease
    • The patient has a serious or life-threatening disease or condition.
  • Inability to join a clinical study
    • The patient is unable to receive the medication in a clinical trial.
  • Lack of suitable available options for the disease
    • The patient has exhausted or cannot be satisfactorily treated with any other currently available therapeutic options.
  • Assessment of benefit risk
    • Benefit of treatment outweighs the risks based on the available clinical data
  • Ethical considerations
    • Ethical considerations relating to fairness to similar patients.
  • Adequate supply of investigational therapy
    • Supply levels of the investigational therapy are available to meet the request.
  • Regulatory considerations
    • Access can be provided in a manner that is compliant with applicable local laws and regulations.
    • The access program will not negatively impact the clinical development or regulatory review or approval of our medicines.
  • Other considerations
    • The patient is under the care of a physician licensed and qualified to administer the medicinal product.
    • The use of that medicine will be in a country where appropriate medical capability for treatment use exists.

We fulfil all regulatory requirements to make public information about our treatment use of our investigational therapy.

Requesting Access:

For patients/caregivers/patient advocates
Requests for early access to our investigational therapy must be made by a qualified physician on your behalf. Discuss available treatment options with your treating physician.

For more information on early access, visit the U.S. Food and Drug Administration (FDA) website

For physicians/healthcare professionals
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 and data privacy, medical criteria, adverse event/safety reporting, treatment monitoring, medicine supply handling and use, and protection of F2G’s proprietary information and/or intellectual property and agrees to perform such duties on a continued basis while the patient is receiving the medicinal product.

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

For EU, Australia and Asia, please contact Shionogi by submitting a request to Shionogi Medical Information or call Shionogi Medical Information at +1 (800) 849-9707 between 9 a.m. and 5 p.m. ET.

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, depending on the availability of the medicinal product and an assessment of the criteria for consideration (see above). The decision to provide access will be based on the patient’s eligibility for access, and the likelihood of the requested medicinal product meeting the patient’s unmet medical need. Decisions will be made in consultation with the patient’s treating physician and in line with local laws and regulations.

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