A European regulatory committee has rejected Eli Lilly’s U.S.-approved Alzheimer’s disease treatment over potentially dangerous risks of brain bleeding and swelling.

Key regulators are not recommending Lilly’s Kisunla be cleared for the European market. The company says it plans to appeal the verdict, a strategy successfully employed by Eisai.

An expert panel of the EU drug regulator, the European Medicines Agency (EMA), on Friday declined to endorse Kisunla (donanemab), Eli Lilly’s (NYSE:LLY) candidate for early Alzheimer’s disease, citing concerns over its risk-benefit profile.