Expanded Access Policy
- Introduction
Minoryx is a clinical stage biotech company committed to the development of safe and effective novel therapies for severe and life-threatening orphan CNS diseases with high unmet medical needs. We are a science-driven company committed to putting patients first. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients.
Clinical trials and the subsequent timely generation of safety and efficacy data are the most effective way of ensuring review and decision making by Regulatory Authorities. This ultimately has resulted in access to new, safe and effective approved medicines for patients.
Expanded access refers to the use of an investigational therapy outside a clinical trial when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient. We understand the need for expanded access programs, and we recognize the importance of having an appropriate policy.
- Criteria
An Early Access program for leriglitazone may be opened if Minoryx determines that all the following criteria are met:
- The disease or conditions is life-threating, seriously debilitating or serious and chronic
- The investigational drug is the subject of an active clinical development program and is not approved in any indication in the country concerned
- The patient is not eligible to participate in a suitable clinical trial
- An adequate supply of the investigational drug exists to perform necessary clinical studies as well as to provide Early Access to patients who do not have alternative treatment options
- There is adequate available data to permit selection of an appropriate dose level
- Early Access does not impede or compromise the clinical development or regulatory approval of the drug under investigation
- There are sufficient clinical data available with respect to both the investigational drug and the disease condition for which the application is being sought, to anticipate that any potential benefits from treatment are likely to outweigh any potential risks to the patient
- Supplied drug is used as clinically indicated from the product information supplied by Minoryx and in discussion with the treating physician
DISCLAIMER: An existing program does not guarantee availability in all countries. Various regulatory mechanisms exist in different countries to provide Early Access to new medicines and as a result, country specific variations for Early Access will occur. Any Early Access to medicines must always comply with the applicable country-specific laws and regulations including medicines importation requirements.
- Statement
At this time, Minoryx believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies. Minoryx continues to assess the eligibility requirements and criteria for Early Access to the investigational drug leriglitazone and will re-evaluate this policy from time to time.
- Learn more
If you are a patient who is interested in accessing our investigational drugs, please speak with your physician. If you have additional questions, please contact clinical@minoryx.com. You may also learn more about ongoing clinical trials by going to www.clinicaltrials.gov and searching for Minoryx.
If you are a physician who is interested in learning more about our investigational drugs, or participating in our clinical trials, please submit a request to clinical@minoryx.com
We anticipate acknowledging receipt of requests sent to this email within five business days.
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