MediciNova Statement on Requests for Compassionate Use under the FDA Expanded Access Program and Right to Try Act
The purpose of this statement is to describe MediciNova’s policy on Expanded Access/Compassionate Use. There are currently two different paths to request to obtain an investigational medical product outside of a clinical study: Expanded Access/Compassionate Use and Right to Try.
Expanded Access/Compassionate Use
Expanded Access/Compassionate Use refers to the use of an unapproved investigational medical product outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who does not meet eligibility requirements for any ongoing trial of the investigational drug, including geographical limitations, and has exhausted other treatment options.
These circumstances may afford the possibility to obtain access to an unapproved investigational medical product only if the regulatory authority, the U.S. Food and Drug Administration or FDA, grants permission to MediciNova to provide a treating physician with supply of its investigational medical product.
Right to Try
Recently, Congress passed the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017 (S.204) that approves patients with a serious or immediately life-threatening disease or condition the opportunity to request investigational medical products from manufacturers with the approval and recommendation of a treating physician.
The meaningful distinction between Right to Try and the Expanded Access/Compassionate Use program is that under the Right to Try Act, the treating physician need not obtain permission from the FDA to treat their patient with the investigational medical product.
Currently, MediciNova is not accepting requests from patients or their advocates (including treating physicians) under the Expanded Access/Compassionate Use Program because of its focus on planned Phase 3 trials to evaluate MN-166 (ibudilast). The Phase 3 trials are important as they will determine the safety and efficacy of MN-166 (ibudilast) in large populations of patients and potentially lead to regulatory approvals, from which patients could benefit.
Accordingly, requests to obtain investigational medical product under the Right to Try Act are not being considered by MediciNova because the FDA would not have the ability to authorize, oversee and review the patient’s course of treatment, which are activities that the Right to Try Act does not mandate.
This policy aligns with MediciNova’s overarching goal to develop safe and effective drug treatments for patients and to obtain regulatory approval of investigational medical products. Clinical drug development is subject to regulatory authorization, oversight, and review in which safety and efficacy data are collected from voluntary participation by patients with the target indication. Controlled clinical drug testing is the best method to ensure that a safe and effective treatment can help the maximum number of eligible patients.
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