After four months of deliberation, the European Medicines Agency (EMA) has "changed its mind" on Lencanermab.

On November 14, the EMA Committee for Medicinal Products for Human Use (CHMP) announced that after re-examining Lencanermab, it recommended approval of Lencanermab for the treatment of mild cognitive impairment or mild dementia caused by Alzheimer's disease, suitable for apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers.

According to regulations, the European Commission is expected to make a final ruling on the marketing authorization application for Lencanermab within the next 67 days. Of course, the European Commission is not in a good position to raise objections, so it is equivalent to approval.

Although we had expected this result four months ago, it can be imagined that there were a lot of discussions in the middle. Foreign media commented that "EMA's attitude towards Lencanermab has reversed 180 degrees."

This time, after Eisai/Biogen submitted the subgroup analysis data of Clarity AD, CHMP, after careful evaluation, still recognized the efficacy benefits of Lencanerumab, so it gave a decision to recommend approval.

The reason why CHMP refused to approve Lencanerumab was that Lencanerumab's performance in the CDR-SB score could not offset its risk of causing serious adverse events. Comprehensive benefit/risk ratio, decided not to approve it.

After conducting subgroup data analysis, CHMP approved restrictions on the indication population, excluding ApoE ε4 homozygotes because such patients have a higher risk of ARIA. The UK also approved this restricted indication in August.

But from another perspective, it means that the safety of Lencanerumab has been recognized for ApoE ε4 heterozygotes and non-carriers.

In addition, although ApoE ε4 homozygotes are the main genetic factor for Alzheimer's disease, they only account for 15-20% of AD patients and are less affected in the UK and EU.

And it doesn’t mean that patients with ApoE ε4 homozygotes cannot use lencanezumab. The FDA has approved the indication for the entire population, and the bleeding risk of patients with ApoE ε4 homozygotes is separately marked in the black box warning. The indication approved by NMPA does not have this mark.

Source: https://mp.weixin.qq.com/