This is how Europe's first Alzheimer's treatment was saved in extremis.

BarcelonaThe first drug to slow the progression of Alzheimer's symptoms, lecanemab, will finally be available in Europe. Its approval has had many twists and turns, and there have been moments when It seemed that it would not end up being approved, but this Tuesday it received the final green light from the European Commission. This is an essential step for the drug, which reduces cognitive impairment by up to 27% in people suffering from this neurodegeneration, to reach healthcare centers throughout Europe. However, there is still some time before Catalan patients can benefit from Leqembi, the drug's brand name, since it is now the turn of the member states to negotiate the price with the pharmaceutical company, and discussions with the Spanish Agency for Medicines and Medical Devices (AEMPS) tend to drag on. ARA reconstructs the backstory of this drug's controversial approval.

First, it was the European Medicines Agency (EMA) that rejected the drug's approval in July of last year, considering that the risks outweighed the benefits for patients. It was a controversial decision that raised a lot of fire, since Alzheimer's patients currently have no treatment available. The scientific community put their hands on their heads because they considered that Europe could be left behind in the fight against the disease And finally, the EMA reconsidered its initial position and authorized the use of lecanemab for a specific group of patients. However, it only authorized it for people who have one copy or no copies of a gene called APOE4, and excluded those with two copies, considering that in this case the benefits did outweigh the risks.

With this decision the EMA calmed the situation and calmed the situation, but the drug still lacked final approval, as it requires the endorsement of the European Commission to obtain it. In a new change of course, last week the committee responsible for evaluating the EMA's decision on lecanemab and making a final decision halted the drug's approval, as it did not reach the required "qualified majority." Seven countries voted against it, and, according to ARA, one of them was Spain. However, the commission issued a "no opinion" on the drug, meaning it did not take a position either for or against it and left its approval hanging in the air, waiting for the committee's chairman, Rainer Becker, to tip the balance in one direction or another.

Spain halts approval

However, this Tuesday, the European Commission granted final approval to the drug, passing the buck to the member states. Experts consulted by ARA believe the blockage of the last two weeks is due to political rather than medical reasons, as for countries like Spain, the drug's entry would entail significant healthcare costs. Not only will it have to finance the approval for all patients who qualify to take it, but it will also require more complementary tests and visits to specialists that have not been done so far. Ultimately, approving it means monitoring more patients, performing more tests, and hiring more professionals to cope with the increased activity.

"It's more cost-effective to kill a drug in an opaque Brussels office than to halt negotiations with the pharmaceutical company once Europe has already approved it because you can't finance it. Public opinion would turn on them," the experts themselves believe, calling for the drug to remain in place. However, they believe it would have been a "scandal" if the drug had not been approved after receiving the EMA's approval.

A few days ago, the Spanish Confederation of Alzheimer's and Other Dementias (CEAFA) warned that Spain would be against approval and that rejection of the drug would lead to the "marginalization" of Spanish patients compared to those in other countries where it is approved, a "limitation" of "limitation."

For example, in the United Kingdom they have authorized it, but they have not included it in the public health portfolio. This means that only those who can pay for it will be able to receive the treatment, a situation that "will generate a very large and difficult to bear inequity" among the population of the United Kingdom and that is not viewed favorably in Europe, the consulted sources add.

Thus, Europe joins the rest of the countries that have already approved it, such as the United States, Japan, China, Hong Kong, South Korea, Israel, the United Arab Emirates, and the United Kingdom. However, a month ago the EMA recommended not authorizing the marketing of Kisunla, a drug containing a protein called donanemab, which slows the progression of the disease in its early stages, and which is approved in other countries, such as the US, and which experts also consider necessary for its approval.