European Medicines Agency approves 14 new medicines but rejects new Alzheimer’s drug

3 months ago 22

The EU’s Medicines Agency (EMA) rejected market authorisation for an early intervention Alzheimer’s treatment, Leqembi (lecanemab), due to concerns over brain swelling and potential bleeding in the brain.

Administered as an intravenous infusion, Leqembi’s active substance lecanemab was developed by Eisai and Biogen as a medicine for treating adults with mild cognitive impairment due to Alzheimer’s disease (AD) and early-stage AD.

The medicine has already received approval from six regulatory authorities, including the US Federal Drug Administration (FDA) and is being marketed in the US, Japan and China.

“We are extremely disappointed by the negative opinion and understand that this may also be disappointing for the wider Alzheimer’s disease (AD) community,” said Chief Clinical Officer at Eisai, Lynn Kramer. “There is a significant unmet need for new innovative treatment options that target an underlying cause of disease progression.”

The EMA’s human medicines committee (CHMP), which met last week (22-25 July), concerned by potential swelling and bleeding in the brain caused by the drug. This was more pronounced in those who had a known genetic risk of developing AD.

The CHMP weighed the potential dangers against the relatively modest benefits of the drug, as observed through a study they had made over 18 months that used a dementia rating scoring system and recommended that it should not receive market authorisation, stating, “The committee considered that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side effects associated with the medicine.”

“We understand that lecanemab is not a wonder drug for all people with Alzheimer’s disease,” said Executive Director of Alzheimer Europe Jean Georges. “However, the existence of a first disease-modifying drug, with a novel mode of action, constitutes an undeniable, major advance for a field which has been waiting for new medicines for over two decades.”

Alzheimer Europe argues that the EMA could have authorised the medicine and requested a clear risk management plan to address potential side effects as part of the authorisation.

14 new medicines receive a recommendation

The committee recommended 14 new medicines, including six biosimilar products for approval by the European Commission and extended the therapeutic indications of 11 medicines, including the star weight-loss medicine Wegovy, at their July meeting.

Novo Nordisk requested an extension to the use of Wegovy to include the prevention of major cardiovascular problems, such as stroke, or death from circulation problems.

The CHMP did not agree to this as it felt that it was already covered by the approved indication for weight management, but will allow Novo Nordisk to update their product information with study results showing a risk reduction of cardiovascular death by 15%.

“We believe that the recommendation to update the EMA label for Wegovy is a significant milestone for people living with cardiovascular disease and obesity,” said Executive Vice President and Head of Development at Novo Nordisk, Martin Holst Lange.

He said the additional information about the study showed the drug’s potential of reducing the risks of major adverse cardiovascular events.

“Wegovy has the potential to protect lives,” he said.