Patient Access: Expanded Access and Right to Try

Levo’s mission is to develop impactful therapies for Prader-Willi syndrome (PWS) based on genetic insights.  Levo believes that this mission is best served when patients have access to therapies that have been approved by relevant regulatory authorities following rigorous safety and efficacy testing.

Well-controlled clinical studies give clinicians, scientists, regulators, patients, and families the clearest opportunity to evaluate the risks and benefits presented by new therapies. The data generated from such studies inform clinical decisions regarding the appropriate care and treatment of patients with PWS.  This information also supports future research efforts by Levo and others.

Because of the importance of well-controlled clinical studies, and to ensure an adequate supply of our investigational products for clinical development, Levo does not make its investigational products available for expanded access or under Right to Try laws at this time.

Accordingly, our investigational products are only available to patients participating in one of our clinical trials. For a patient with PWS to participate in a clinical trial, she or he must meet specific eligibility criteria that are designed to help clinical researchers gather the data necessary to evaluate an investigational therapy and to help mitigate risks to patients during the investigational phases of product development.  All medical treatments are associated with risks, including the products that Levo investigates in its clinical trials.

This policy is subject to change. Levo will revisit the policy periodically and amend it as appropriate. Individuals with questions regarding this policy can contact Levo by email at: