Expanded Access Policy

 

 

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Myovant is focused on becoming the leading global biopharmaceutical company focused on the innovative treatment of women’s health and other endocrine diseases in areas of high unmet medical need, and improving the lives of millions of patients suffering from these diseases.

As part of our work, we conduct clinical trials to evaluate the safety and efficacy of investigational drug candidates. Clinical trials are controlled research studies in humans designed to determine if an investigational drug candidate is safe and effective. Myovant encourages awareness of and participation in our clinical trials. Please visit http://myovant.com/pipeline and http://clinicaltrials.gov for more information about our clinical programs.

In certain cases, when it is not possible for a patient to participate in a clinical trial and all other available medical options have been exhausted, a patient’s doctor may attempt to seek special access to an investigational drug candidate for that patient outside of a clinical trial. This is known, among other terms, as expanded access. For a patient to obtain access to an investigational drug candidate through expanded access, the patient’s physician, the drug’s sponsor and the U.S. Food and Drug Administration must all approve the use.

Making decisions about requests for expanded access to an investigational drug candidate is a complicated, multi-faceted, patient-specific and fact-heavy decision. This is because investigational drug candidates—which, by definition, have not yet obtained regulatory approval—may present numerous risks for the patient and the clinical development program. For patients, expanded access may involve potential safety risks and/or offer false hope. Likewise, for the clinical development program, expanded access may delay or jeopardize the approval of a new therapy or treatment. None of our product candidates have clinical data demonstrating their safety and efficacy. For these and other reasons, therefore, Myovant believes that participating in clinical trials is the best way for patients to access investigational drug candidates and, at this point in time, we have not established an expanded access program.

If a treating doctor finds that expanded access may be the only option for a patient, the doctor should formally contact Myovant to make a written request. The following are some of the general considerations for expanded access: the patient must be suffering from a serious or immediately life-threatening disease for which no satisfactory treatment alternative exists; the medication must be undergoing clinical development by Myovant and the provision of the medication must not compromise the clinical development program (e.g., the initiation, conduct, or completion of trials) or the potential regulatory approval of the medication; Myovant must have adequate supply of the medication; sufficient data must exist to support its use in the specific clinical condition from which the patient suffers and adequate data must also exist to identify an appropriate dose for use in such patients;  overall, the potential benefit to the patient must outweigh the potential risks to the patient. Questions about or requests for expanded access to Myovant investigational drug candidates can be submitted to: expandedaccess@myovant.com.