MediciNova, Inc. announced its experimental therapy MN-166 (ibudilast) received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with amyotrophic lateral sclerosis (ALS). The announcement arrived just after MediciNova presented positive interim data from ibudilast‘s ongoing clinical trial to evaluate the drug’s efficacy and safety in the treatment of ALS.
Fast Track designation is awarded by the FDA to facilitate the development and expedite the review of novel drugs to treat serious or life-threatening diseases that show the potential to address urgent and unmet clinical needs. This designation is also important to emphasize constant communication between the FDA and the developer throughout the drug development period and review process, this way improving product development efficiency. This means that Fast Track designation can potentially shorten the timeline to the final drug approval.
“We are very pleased that MN-166 has received Fast Track Designation for ALS and believe this validates its potential to address unmet medical needs in this life-threatening disease. We look forward to providing further updates as our development program progresses,” Yuichi Iwaki, M.D., Ph.D., President and CEO of MediciNova, Inc. noted in a news release.
To receive Fast Track designation, a drug must not only be intended to treat life-threatening diseases or conditions, but also demonstrate its potential to address currently unmet medical needs. With this label, a drug can be eligible for:
- Constant meetings with the FDA to debate drug development plans and ensure the appropriate data collection needed to achieve drug approval;
- Accelerated Approval status — approval grounded on the effects of a surrogate or substitute endpoint which is predictable in clinical benefits or on a clinical endpoint that can be analyzed prior to irreversible morbidity;
- Priority Review status — with an FDA goal to finish the review process within six months of submission;
- Rolling Review status — meaning a sponsor can submit finished sections of a New Drug Application (NDA) for the FDA to review separately rather than waiting for all sections to be ready, accelerating the review process.
MN-166 (ibudilast) is already marketed in Japan and Korea since 1989 to treat post-stroke complications of bronchial asthma. MediciNova licensed MN-166 (ibudilast) from Kyorin Pharmaceutical as a potential treatment for relapse-remitting multiple sclerosis (RRMS). The drug’s anti-neuroinflammatory and neuroprotective characteristics have been demonstrated in preclinical and clinical trials and may be of potential utility in neurodegenerative diseases like Multiple Sclerosis and ALS, substance addition or chronic pain.