Expanded Access

Access to Investigational Medicines

To serve patients, KalVista Pharmaceuticals (KalVista) engages in clinical research with the goal of obtaining regulatory approval of its products.

Clinical trials allow KalVista to evaluate new treatments in patients in order to generate the safety and efficacy information needed to obtain approval of those treatments and make them available to the broader patient population. Outside of a clinical trial, access to KalVista’s investigational products would be considered only under limited circumstances, and as permitted by applicable law, in the following situations:

   - KalVista may provide continued access to its investigational products to participants in a clinical trial once the trial is complete.

   - KalVista may provide physician-requested expanded access (also known as compassionate use) to its investigational products to patients who cannot join an active clinical trial of the investigational product providing the criteria below are met.

Criteria for Considering Requests for Expanded Access

 

- The patient has a serious or immediately life-threatening disease or condition.

- There is no comparable or satisfactory alternative treatment for the disease or condition.

- Sufficient clinical evidence of safety and effectiveness in the indication has been established and the potential benefit justifies the potential risks. In this context, the investigational product would have generally completed Phase 2 clinical studies.

- The product is under active development in the indication and expanded access will not interfere with the development of the product.

- KalVista has adequate supply of the investigational product.

- There is a regulatory mechanism in the country or region to support expanded access.


Process for Requesting Expanded Access

Patients interested in seeking expanded access to a KalVista investigational product should talk to their physician. A treating physician may request information about applying for access to one of KalVista’s investigational products by email at expandedaccess@kalvista.com. KalVista will aim to acknowledge receipt of a request for expanded access within five business days.

All physicians who receive any of KalVista’s investigational products through expanded access are required to comply with all applicable laws and regulations, and contractual conditions, including those relating to safety reporting.


 

`