Over 50 clinical trials with a single focus:Improve lives
Expanded Access/Compassionate Use
Cytokinetics is committed to translating our advanced understanding of muscle biology into novel treatments that may help people with debilitating diseases in which muscle performance is compromised and/or declining. We recognize that people with these diseases are in desperate need of treatment options and interested in the possibility of our making our investigational therapies available upon request prior to potential regulatory approval.
Any access to our investigational therapies would have to be fair and equitable, safeguard the welfare of patients, and not put at risk the completion of our ongoing research and development. Cytokinetics has sought advice from physicians, ethicists, and patient advocates on these important considerations. Through these interactions, we have concluded that sustainable, long-term availability of our investigational therapies can best be achieved following demonstration of the investigational drug’s safety, tolerability, and effectiveness through controlled clinical trials, which may hopefully address the requirements of regulatory agencies. Offering pre-approval access outside of a controlled clinical trial at this time may jeopardize the conduct of our ongoing clinical trials and may also prevent or delay our broader development programs, which would likely then result in a setback to all patients in need. Accordingly, we have reached the difficult decision that it would not be appropriate to provide access to our investigational therapies outside of our clinical trials at this time.
More information on our clinical trials is available on clinicaltrials.gov and on our website here https://cytokinetics.com/clinical-trials/
We are grateful to the people and families living with debilitating diseases in which muscle performance is compromised and/or declining who have participated in our clinical trials. We may consider potential expanded access to our investigational therapies as we learn more about them in clinical trials.
For additional information about this policy, please contact email@example.com. Responses will be provided within approximately one business week.