Stimulating thinking through
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
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
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
Did you receive Priority Review?
The FDA classified the edaravone application as a standard
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
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
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
For other questions about access to edaravone in the US, please