Minovia Therapeutics is dedicated to developing new mitochondria-based therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities.
Consistent with our mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies. In these circumstances, Minovia will consider providing a requesting physician with pre-approval access to a specific Minovia investigational drug, for the treatment of an individual patient outside of a clinical trial. Due to complex manufacturing procedures, expanded access can only be provided by physicians treating at sites currently enrolling patients under clinical trials. The conditions which must be met to consider a patient for expanded access include the following:
• 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 option, or no treatment option exists;
• 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;
• 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, 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; and
• Adequate supply of the investigational drug is available.
All requests must be submitted by physicians currently at our open clinical sites. Minovia will require detailed information to fully evaluate a request. We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Minovia is committed to evaluating all requests in a fair and equitable manner, and each request, considered on a case-by-case basis, will be given careful consideration by Minovia. The requesting physician must obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting.
Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to info@minoviatx.com. We regularly monitor this mailbox and will use our best efforts to ensure that initial response times for each submitted request will occur within 10 business days after receipt.