FOR DOCTORS AND PATIENTS
Expanded Access
Graviton is dedicated to developing novel therapies that have a transformative effect on disease, and to serving patients, their families, and their communities.
Our commitment
Graviton’s mission is to bring innovative medicines to patients with serious or life-threatening illnesses or conditions; we are focused on facilitating the clinical trials necessary to gain regulatory approvals to make our medicines broadly available to patients as quickly as possible.
At Graviton we also acknowledge that there are seriously ill patients who are not eligible for clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors.
For these circumstances, Graviton will consider providing a requesting physician with pre-approval access to a specific Graviton investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met.
Conditions for pre-approval access
The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment options.
The patient is not eligible for any ongoing clinical trial of the investigational drug.
The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition.
The treating physician is qualified and able to submit and manage the request through the FDA. Furthermore, the physician must be qualified and knowledgeable in the treatment of the disease or condition.
It is logistically feasible for Graviton to provide the patient with the investigational drug.
The requested use complies with applicable laws and regulations.
A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, that supports making the investigational drug available.
Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access.
Adequate supply of the investigational drug is available.
Expanded Access Requests
Requests for expanded access must be submitted by the patient’s treating physician and will be assessed on a case-by-case basis.
Graviton may require more detailed information to fully evaluate a request.
The requesting physician must agree to obtain the appropriate regulatory and ethics committee approvals and must comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting.
Each request will be carefully considered by Graviton, whose decisions are final.
Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests below.
Graviton aims to acknowledge submitted requests within 5 business days of receipt.
Submit an Expanded Access RequestRequests should include:
- A medical summary of the patient’s condition.
- The rationale for requesting the investigational therapy.
- Confirmation of the patient's ineligibility for a current clinical trial.
- Attestation from the physician indicating their willingness to manage the treatment.