Vaderis Therapeutics AG Policy on Expanded Access to Investigational Drugs
Vaderis Therapeutics AG (“Vaderis”) is a clinical-stage pharmaceutical company committed to developing effective interventions for HHT, to improve patients’ lives. Vaderis is committed to bringing innovative, safe and effective therapies to patients by conducting rigorous clinical trials and obtaining marketing approval by the FDA and other regulatory authorities.
Expanded access programs, also known as “pre-approval access” or “compassionate use”, are potential pathways for patients to receive investigational drugs that are not yet approved by the FDA or other regulatory authorities but may be beneficial for patients with serious or life-threatening conditions. Under these programs, patients who are unable to participate in a clinical trial may potentially receive the investigational drug outside of clinical trials. Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug.
The following is Vaderis’s policy for responding to requests for individual patient access to investigational drugs that are intended to treat serious diseases.
Expanded Access Policy
To serve patients, Vaderis conducts clinical trials with the goal of obtaining regulatory approval of its products. Enrolment in a clinical trial is currently the only method through which access to Vaderis’s investigational drug, VAD044, is provided prior to its potential approval by applicable regulatory authorities and subsequent commercial availability. Our clinical trials have been designed to help demonstrate that our investigational drug will meet the safety and efficacy standards required for approval by applicable regulatory authorities, such as the U.S. Food and Drug Administration, and therefore represent the best and safest access for patients. We will continue to evaluate the possibility of further expanded access as we advance development of our investigational medicines. As authorised by the 21st Century Cures Act, Vaderis may revise this posted expanded access policy at any time. The availability of this policy or any revised version shall not serve as a guarantee of access to VAD044 or any other investigational medicines by any individual patient. Please visit https://clinicaltrials.gov for more information about current Vaderis clinical trials.