EDG-7500
EDG-7500 is a novel oral, selective cardiac sarcomere modulator for individuals living with symptomatic hypertrophic cardiomyopathy (HCM).
EDG-15400
EDG-15400 is a novel oral, selective cardiac sarcomere modulator for individuals living with heart failure (HF).
Our Expanded Access Policy
Edgewise Therapeutics (Edgewise) is a clinical-stage company dedicated to developing innovative therapies for serious cardiovascular diseases. We are committed to conducting clinical trials to evaluate the safety and efficacy of investigational therapies to obtain the necessary marketing approvals that allow physicians to prescribe them so individuals may have broad access.
New investigational therapies must be reviewed and approved by a regulatory authority, such as the U.S. Food and Drug Administration (FDA), before they become commercially available.
In some circumstances, a treating physician may make a request to provide an unapproved therapy to a qualifying individual, which must be approved by the FDA and supported by the pharmaceutical manufacturer. This process is called expanded access, sometimes known as compassionate use. Expanded access programs are not offered by every pharmaceutical manufacturer or for every investigational therapy. Because our investigational therapies are in early testing and much remains unknown about their safety and efficacy, Edgewise does not currently offer an expanded access program.
Clinical trials are designed to evaluate whether an investigational therapy is safe and effective for patients. Data generated by clinical trials are evaluated by regulatory authorities to determine whether the investigational therapy can be approved for broad use. Edgewise believes that participation in a clinical trial is the most appropriate way to access our investigational therapies. We believe this supports the goal of advancing most rapidly towards making our investigational therapies available to as many as possible.
We encourage patients and their families to speak with their physicians about possible clinical trial participation. Information about our investigational therapies and ongoing clinical trials can be found on www.edgewisetx.com and www.clinicaltrials.gov. We reserve the right to review and amend this policy in the future, including based on information from ongoing and future clinical development.
