The U.S. approved an Alzheimer's drug. Seven patients subsequently died

The U.S. approved an Alzheimer's drug. Seven patients subsequently died

Three others also suffered lasting disabilities, according to FDA reports obtained by a Freedom of Information Act request

The US Approved an Alzheimer's Drug. Seven Patients Subsequently Died

Despite the known risks of patients experiencing life-threatening side effects, prescribing standards vary widely among medical centers.

The EU Commission has the last word, but the EMA's assessment is central: a new Alzheimer's drug does not make it into the EU.

The European Medicines Agency (EMA) did not approve the active substance donanemab, but the risks for side effects such as brain swelling and brain bleeding were too high. In the USA, Japan, China and the UK, however, it was approved.

Alzheimer Europe | The European Commission refers lecanemab decision to Appeal Committee

On 1 April, Eisai and Biogen announced that the European Commission has decided to refer the marketing authorisation approval decision of lecanemab in the EU to the Appeal Commi

Lilly to appeal after CHMP rejects Alzheimer's drug Kisunla

The CHMP has advised against EU approval of Eli Lilly's Alzheimer's drug Kisunla, potentially handing an advantage to Eisai/Biogen's rival drug.