Image: dpa
New Alzheimer’s drugs are causing a stir, including in Bremen. Neurologist Duning longs for the medicines. Pharmacologist Mühlbauer does not want them to be approved.
Both are proven medical specialists: Thomas Duning, head physician of the neurology clinic at the Bremen-Ost Clinic, and Bernd Mühlbauer, director of the Institute of Pharmacology at the Bremen-Mitte Clinic. The layperson might assume that they would come to similar conclusions if they evaluated the same drug.
At least with the Alzheimer’s drugs aducaumab, lecanemab and donanemab, the opposite is the case. While Duning has high hopes for these drugs and can hardly wait for them to come onto the market in Germany, Mühlbauer rejects the funds. He hopes that they will not even be approved in Europe.
Risk of local brain swelling
Image: Radio Bremen
Essentially, the drugs in question are antibodies that, according to the Alzheimer Research Initiative, remove harmful protein deposits in the brain. The drugs are already approved in many countries, including the United States, China, Japan and South Korea, but not yet in Europe.
And rightly so, says Mühlbauer and points out the side effects. “In the approval study, local brain swelling and microbleeds occurred in 17 percent of the test subjects,” he writes in the specialist journal AVP. This observation is “worrying”. Therefore, in terms of patient safety, it is good news that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) voted against the approval of lecanemab in July this year. In fact, the CHMP’s negative attitude towards lecanemab also had to do with the risks mentioned by Mühlbauer justified.
Is Europe lagging behind?
Image: Radio Bremen
But the Bremen neurologist Thomas Duning thinks this is a mistake. He hopes that the EMA will approve the drug in the near future. “It’s only the Europeans who have a hard time with it,” he says, pointing to successes in treatment with antibodies in the USA, for example.
Duning is not alone in his hopeful assessment of the new drugs. The German Society for Neurology (DGN) also writes in one opinionthe new antibodies are “a milestone”.
For exactly this reason, the German Center for Neurodegenerative Diseases (DZNE) finds the EMA’s decision “incomprehensible“. The center reports: “Alzheimer’s is a global pandemic and the recommendation for approval of lecanemab would have been an important step in getting this serious disease better under control in Europe too.”
“Question of perspective”
Image: dpa
Anke Christians from the medical editorial team at Norddeutscher Rundfunk attributes the differences of opinion among doctors regarding Alzheimer’s drugs primarily to their different perspectives. “It’s a question of perspective,” she says. The majority of neurologists are pleased that thanks to the new means there is finally a way to treat Alzheimer’s causally – at least in the early stages. They would probably also have in mind that developing a drug costs a lot of money. In order for it to be further developed, initial approval is even more important.
However, Christians also find it understandable that the Bremen pharmacologist is primarily concerned with the risks of the new drug. The studies on the medication revealed some ambiguities. Neurologists have overwhelmingly spoken out clearly in favor of the new medications. Nevertheless, there are also important critical voices in Alzheimer’s research that are in line with Mühlbauer. So advocated The Alzheimer Research Initiative also stated that “the safety of those affected was given greater weight when weighing the benefits and risks.”
Final decision on Alzheimer’s medication pending
But whether it will stay that way is questionable. Henry Fitt, spokesman for the EMA, said that the EMA Human Medicine Committee is currently re-examining the marketing authorization application for lecanemab. “The assessment of donanemab is also ongoing,” adds Fitt.
source: buten and within.
This topic in the program:
buten within, September 20, 2024, 7:30 p.m