Europe backtracks and endorses second drug to slow Alzheimer's progression

BarcelonaYet another twist in the fight against Alzheimer's in Europe. The European Medicines Agency (EMA) has reversed its decision and recommended authorizing the marketing of Kisunla, a drug containing a protein called donanemab that slows the progression of the neurodegenerative disease in its early stages. reject your authorization Four months ago, the European regulator's Committee for Medicinal Products for Human Use now believes the drug from the US company Eli Lilly has proven beneficial for a specific type of patient and recommends it for people with one or no copies of a gene called APOE4. This excludes those affected who have two copies of this gene.

Alzheimer's disease is characterized by the unusual aggregation inside and outside neurons of a peptide (a protein fragment) called beta amyloid and the protein known as tableau. It's not known why this happens, but this is most likely what causes cells to break down and the brain to gradually atrophy. Donanemab is an antibody that attacks beta amyloid plaques and is aimed at people who suffer from early symptoms of the disease, such as mild cognitive impairment and mild dementia, as well as the presence of these plaques in the brain. The antibody has been shown in clinical studies to reduce cognitive and functional decline by up to 35%.

When it rejected its approval last March, the EMA warned that other studies indicate that one in three patients may suffer inflammation and bleeding. According to this research, 1.6% of trial participants suffered serious consequences, and three people died. Given this scenario, the European agency considered that it should not recommend approval of a drug that is authorized in other countries such as the United States, the United Kingdom, China, and Japan. It has now reversed itself and authorizes it only for those patients who meet the requirements and have a lower risk of suffering adverse effects.

Lecanemab leads the way

This is the second time Europe has reversed itself on a successful Alzheimer's drug. On that occasion, it stood alone when it rejected the approval of lecanemab, the first drug shown to be effective in slowing the progression of the disease's symptoms. Experts around the world were shocked, and finally, the EMArectifiedand recommended that Member States authorize the marketing of Leqembi, the drug's brand name. According to several studies, this drug slows cognitive decline in people with Alzheimer's by 27%.

However, the European agency only authorized it for patients in the early stages of the disease who are genetically less likely to suffer side effects, as has now occurred with donanemab. Specifically, it only recommended it for patients who have one copy or none of a gene called APOE4, and excludes those with two copies. Despite the medical endorsement, the ARA already explained that some Member States—including Spain—tried to halt the drug's approval when it was being evaluated by the European Commission.

The experts consulted by the ARA explained at the time that the blockage of leqembi was for political, not medical, reasons, since for countries like Spain, the drug's entry would entail significant healthcare costs. Not only will it have to be funded for all eligible patients, but it will also require more complementary tests and specialist visits than have been done so far. This means resizing the healthcare system to monitor more patients, perform more tests, and hire more professionals to cope with the increased activity.

All in all, the European Commission finally granted final approval to lecanemab, and now each member state is conducting its own analysis. It remains to be seen whether the same thing happens with donanemab, with some countries attempting to stop it in Brussels, or whether it receives final approval without further twists and turns. In the second scenario, it will become the second drug approved in Europe to slow the symptoms of Alzheimer's.