The company responsible for marketing by the European pharmaceutical company, which is responsible for the sluggish Donnamab, will ask social officials to reconsider the decision. The European Commission will make a final decision.
EU regulators have blocked a drug Against AlzheimersIt has already been recognized in the United States and the United Kingdom, for its possibility Side effects: According to the European Drug Agency (EMA), these can become death.
He Donamumab This is a drug marketed by Lily in the name of Kisunla. This is an antibody, and according to its approval phases, reduces progress Neurosis In Initial venues Disease. The product is managed Pathway Once a month. If this was not suspended, Tonnemab would have been the second drug recognized by EMA in two decades.
But the agency’s expert panel has confirmed that the active ingredients of the drug will indicate death risks for some of its potential patients: “The benefits of Kisunla are not enough to compensate for their risks.” Agency In a statement. His experts quote the contradictions attached to the amyide, which can cause a side effect that can cause inflammation and cerebral bleeding.
Alzheimers are the most common way of dementia and Affects about seven million people in Europe, According to the European Brain Council. Gisunla was created Patients with accumulation of beta acidoid plates In the brain, it is common during the development of this disease. The drug adheres to the amoid beta, reduces the accumulation of plates and delays the progression of the disease.
A Medical testA late gridKisunla diminished the development of dementia symptoms Up to 35% After 18 months. But three people diedTwo of them go with a certain type of gene that increases the risk of Alzheimer. Lily has demanded that Kisunla be given to patients who do not tell Jean, but the EMA has completely rejected their commercialization.
Alzheimer’s European Research Director Angela Bradshah, although the community of dementia was interested in this new medicine, This is not a wonderful drug or treatment: “They are doing better quickly,” he explains to ‘Euro -Health’, but they also cause some safety problems. “
Alzheimer’s Europe, which has all three dozen countries, points out that the patient’s safety is important, but the controlled distribution of the drug may have allowed those Europeans in the early stages of Alzheimer. But without the risk of side effectsAccess new treatment.
Donnamab in the hands of the European Commission
The EU has 67 days to follow EMA’s recommendations. It would be an official and legally bonding decision. Last year, the EMA canceled the initial rejection of another pharmacy against Alzheimerrs, which is also a risk.
After voting against lecembi to a large patient in the beginning, Creature He suggested that the drug was given to those who had only a copy of the gene in November or had nothing to do.
Lily said It will ask EMA Reconsider your decision on Kisunla. “Through the rexeman process, we hope that we can continue our conversations with the agency to bring Tonnemapp to millions of people from all over Europe,” those who are suffering from this stimulant and deadly disease, “said Ilia Yfa, the head of the Lily International.”
The drug is already recognized The United States, Japan, China and the United Kingdom. But British patients are currently not provided with the National Health Service (NHS), their price control system said drug It is not profitable enough.
Bradsha points out that high cost of drugs such as Kisunla and Lecemmbi may cause problems because they are expected to cost some 25,000 euros per year They also need to monitor products, brain scanners, gene tests and side effects from time to time. “Although the drug is expensive, everything around it is incredibly expensive because they are not easy to drink drugs,” Bradshah says.
