A Japanese Health Ministry expert panel has declined to endorse Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab), citing inconclusive trial results and the need for more efficacy data before signing off on an approval.

Biogen along with Japanese marketing partner Eisai pledged to “actively engage” with Japan’s  Pharmaceuticals and Medical Devices Agency on additional data requirements and said they are committed to quickly bringing Aduhelm to patients in Japan ― a country which has a significant elderly population.

The decision arrives shortly after the European Medicines Agency decided against authorizing Aduhelm, noting the data didn’t show a strong clinical benefit or demonstrate adequate safety.