Medical Affairs

Stimulating thinking through
scientific exchange.

Our Medical
Affairs Team

The Medical Affairs team serves as the primary interface with the medical and scientific communities in the US through informational scientific exchanges and facilitation of educational and research programs.

Questions About
Edaravone Access

What is edaravone?

Edaravone is an investigational intravenous treatment for amyotrophic lateral sclerosis, also called ALS or Lou Gehrig’s disease. It is not currently available in the US. A New Drug Application (NDA) is currently under review by the US Food and Drug Administration (FDA).

What is the status of the FDA review?

Edaravone is currently under review by the FDA for the treatment of ALS and a decision is expected by June 16, 2017.

Did you receive Priority Review?

The FDA classified the edaravone application as a standard 10-month review.

Can I get access to edaravone in the US prior to FDA approval of the NDA?

Our investigational drug, edaravone, is currently under review by the FDA for the treatment of ALS and a decision is expected by June 16, 2017.

MT Pharma America understands the urgency that exists for patients and caregivers, so we took the unique approach of filing an NDA using clinical trials conducted outside of the US. This step was critical in expediting the NDA filing and review by the FDA. However, because there is no Investigational New Drug (IND) program or active US trials, several additional importation steps become necessary to make edaravone available in the US. After meeting with patient representatives, advocacy groups, and clinical research organizations exploring every known option, it is highly unlikely that the steps required to bring the drug into the US can be completed prior to the FDA decision on the NDA.

We will continue to interact with the FDA, clinical experts, and advocacy groups as the edaravone NDA is reviewed and will communicate information as it becomes available as appropriate.

For other questions about access to edaravone in the US, please call 1-888-292-0058.