Expanded Access Policy Disclosure

Tenaya is committed to improving and extending the lives of individuals by discovering, developing and delivering therapies that address the underlying causes of heart disease. The most efficient and effective way to ensure patients can benefit from our investigational medicines in the future is through clinical trials carried out in collaboration with researchers, patient advocacy groups and physicians.

We recognize that some patients may not qualify for clinical trials and may seek access to investigational medicines through the FDA’s Expanded Access pathway. We welcome these requests and are dedicated to assessing each case with care and a sense of urgency. This policy outlines our approach to evaluating such requests.

Scope of Policy

This Expanded Access Policy applies only to the investigational drug product TN-201, which is currently under development for the treatment of HCM due to MYBPC3 gene mutations. Requests will only be reviewed for pediatric patients having confirmed diagnosis of MYBPC3-associated HCM with confirmed pathogenic or likely pathogenic MYBPC3 mutation.

Access to other investigational products in our pipeline is only through participation in clinical trials and we do not accept expanded access requests for our other pipeline products at this time. Participation in a clinical trial is the best way to safeguard the welfare of patients and provide fair and equitable access to these medicines. Offering access outside of clinical trials could jeopardize the conduct of these trials, delay or prevent future clinical development programs and potentially create a setback to all patients in need. We will review and reevaluate our expanded access policy as new data becomes available.

Criteria for Consideration

Requests for expanded access may be considered if the following conditions are met:

  • The patient has a serious or immediately life-threatening condition.
  • No comparable or satisfactory alternative therapy is available.
  • The patient is ineligible or unable to participate in ongoing Tenaya-sponsored clinical trials.
  • Sufficient clinical data exists to support a favorable risk-benefit profile for the proposed use.
  • Providing the drug will not interfere with ongoing clinical trials or development plans.
  • The request complies with applicable Health Authority (i.e., FDA or Ministry of Health) regulations and local laws.

Additional criteria regarding the therapy, its development program, the patient, or other circumstances may impact eligibility.

How to Submit a Request

Requests must be submitted by a licensed treating physician and should be sent to: ExpandedAccess@TenayaThera.com

We aim to acknowledge receipt of all inquiries within 5 business days.

Limitations

Because the circumstances of each request are different, there is no guarantee that expanded access will be granted. Tenaya reserves the right to decline requests that do not meet the considerations outlined above, subject to product availability, regulatory approval, and internal review.

Additional Information

Find information on currently enrolling clinical trials for Tenaya’s investigational therapies on clinicaltrials.gov, www.HCMStudies.com and www.ARVCStudies.com

Tenaya Therapeutics reserves the right to revise this policy at any time and this posting will be updated should there be any policy change.