MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the protocol and determined that MediciNova may proceed with a Phase 2b/3 clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS). If this potentially pivotal trial is successful, the Phase 2b/3 efficacy and safety data is intended to support a New Drug Application (NDA) for MN-166 (ibudilast) in ALS. The trial will be fully funded by MediciNova.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are very pleased to have successfully completed the FDA review period and look forward to initiating patient enrollment shortly. The efficacy and safety data from this trial will potentially support an NDA and may lead to FDA approval of MN-166 for ALS. While we acknowledge this was an important milestone, and we have a clear path forward, this moment is of great importance to the ALS community. We give them our sincerest appreciation for their patience and optimism.” Dr. Iwaki further commented, “Patients will be eligible to receive study drug from MediciNova after completing the required treatment period in this trial.”
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