2023-11-13 19:05:32
A monoclonal antibody, which works against Alzheimer’s by reducing beta-amyloid plaques, to be launched in Europe next year; the development of a new drug aimed at targeting the Tau protein; the work for new, more patient-friendly formulations such as the subcutaneous one. These are some of the projects that Biogen has in the pipeline for Alzheimer’s disease, a field in which it is intensifying its efforts, despite the difficulties posed by the pathology, which has also pushed some companies to abandon the field. “We expect that for the next 25 years, Biogen will be significantly involved in the search for new treatments for this disease, in addition to providing current therapy,” Biogen president and CEO Christopher A explains in an interview with time.news Health. Viehbacher.
“On Alzheimer’s we had a turning point – recalls the manager – With lecanemab”, developed with Eisai, “we discovered that we had the right antibody to be able to introduce enough drug into the brain and reduce the beta-amyloid plaques to actually be able to see a cognitive benefit. And now we also know that the earlier we treat – before too many neurons die – the better. As for Europe, the request for authorization for the drug was submitted to the European medicines agency EMA in January this year And if all goes well, we would expect to get approval in the first quarter of 2024,” announces Viehbacher. “And we expect to also present the subcutaneous formulation in the EU” of lecanemab-irmb, and the other projects on which we are working.
“Europe has an older population than most other parts of the world and Alzheimer’s is therefore a very important health problem. We do a lot of clinical research in Europe.” The first fruits are now being reaped from the long years of research and development.
“Biogen and many even larger companies have spent tens of billions of dollars to find a therapy for this disease. And initially they all failed – recalls the CEO – And it is precisely because of these failures that the neurological community began to ask whether it was worth trying to remove the amyloid plaques. The problems to be faced were different: bringing the drug to the brain which is well protected by the blood-brain barrier; understanding the right patients to treat, because the plaques themselves do not cause the problem, but create a reaction biochemistry that starts killing neurons. And once too many neurons are lost, it’s very difficult to get any kind of benefit. So early decisions were affected by these issues.”
Then there was what Viehbacher defines as the turning point of lecanemab: this drug against Alzheimer’s “was the first to have full approval in the United States – he recalls – And now we have to continue working on other things. Today we know that in The reality is that by the time symptoms appear it’s almost too late. And that plaques start to develop 10-20 years before you experience a symptom. So we’ve started a study, called ‘Ahead’, which is trying to look at patients before they experience symptoms”.
Another trial addresses the problem of the return of plaques, he continues, and “we are examining a maintenance therapy that allows us to treat patients in such a way as to avoid this”. Since patients will be taking these drugs for longer, the ‘logistical’ issue was also taken into consideration: “Right now the patient has to go to an infusion center every two weeks. How can we make his life easier “That’s why we have developed a subcutaneous injection and will submit it for approval next year,” says the manager.
As for the ‘fight’ against other factors implicated in Alzheimer’s, “at an important conference on Alzheimer’s, we have just demonstrated that a new drug inhibits Tau”. It’s an observation that’s been made in “a small number of patients and it’s early stage, but we’ve seen really significant improvements in Alzheimer’s. So now we’re going to spend hundreds of millions of dollars over the next few years to show that even reducing Tau protein tangles has benefits. Do we believe in all these drugs? Yes, really. And we will continue to work on this”, concludes Viehbacher.
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