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Alzheimer's drug, which failed early tests, which are now effective, is referred to the FDA



  Multistory glass office building.
Enlargement / The exterior of the Biogen Technology headquarters in Cambridge, Massachusetts.

Experimental treatment of Alzheimer's is referred to the Food and Drug Administration for approval ̵

1; despite the fact that it performed a "useless analysis" and was abandoned by its manufacturer only months ago.

In March, the biotechnology company Biogen stopped two phase III clinical trials of the aducanumab antibody drug after preliminary data analysis suggested it was intended to fail. The decision to excavate the closely monitored drug sent Biogen's future and queued up. Shares fell more than 25% on the day of the announcement, reducing about $ 18 billion of the company's market value, according to Bloomberg at the time.

But this March decision is based on data collected only in December 2018. Additional data from recent months has continued to roll – and that told a different story, according to Biogen.

Those who received higher doses of education have "received significant benefits from cognition and function measures such as memory, orientation and language," the company said. , These patients also saw the benefits of day-to-day activities, such as managing their personal finances, cleaning, laundry, shopping and traveling outside their homes.

In a statement, Biogen CEO Michel Vunacos said: [19659008] With such a devastating disease that affects tens of millions around the world, today's message is truly a listen in the fight against Alzheimer's disease. This is the result of groundbreaking research and is a testament to Biogen's unwavering determination to follow the science and do the right thing for patients. We hope for the prospect of offering patients the first therapy to reduce the clinical decline in Alzheimer's disease and the potential application of these results for similar approaches targeting amyloid beta.

Biogen said it expects the drug to be approved by the FDA in early 2020. News sent 42% of Biogen stock early Tuesday, bringing it back to where it was before the March crash.

And what has changed? high doses of educationab. These data come from two separate studies called EMERGE (involving 1638 patients) and ENGAGE (involving 1647 patients). Both were Phase III multicenter, randomized, double-blind, placebo-controlled, parallel study groups testing the safety and efficacy of 18-month education schedules at two different doses.

Prior to initiating these studies, studies suggest that education can help clear the hallmarks of blunt amyloid-beta peptides that accumulate in the brains of Alzheimer's patients. But clearing these lumps from blood vessels in the brain comes with the potential risk of vascular damage, which can trigger an immune response and swelling.

As Ars reported in 2016, the results of a Phase I trial seem to confirm this risk. Although the drug cleared the lumps, the higher the education dose of proc in the process, the more signs of cerebral swelling and hemorrhage – manifesting as ARIA-E, or amyloid-related picture-edema abnormalities.

That the Phase I trial began with 165 participants, 32 of whom received the higher dose. Of these, 15 developed ARIA-E and 10 patients dropped out of the study due to adverse events, an alarming sign.

Phase III

The problem persists in both Phase III trials. ARIA-E and headache are the most commonly reported adverse reactions in both, and early data are predominantly from lower-dose patients who are less likely to develop ARIA-E.

When Biogen conducted a uselessness analysis in March, the company had data from only 1,748 patients who completed a full 18-month experimental treatment. As the data continues to spread, Biogen has collected data on another 318 patients who completed the 18-month treatment. These were a total of 2066 patients (63%) who had completed the treatment of 3 285 patients initially enrolled in the two studies. It is not clear how many of the remaining 37% of patients dropped out due to adverse events.

However, the additional data have more results than the patients receiving the higher dose. Together, they tilted the scale to show that these higher doses resulted in "a significant reduction in clinical decline from baseline." However, the results are only statistically significant for one of the two studies (EMERGE, not ENGAGE).

The company says it has had discussions with the FDA about the drug's approval.

There are currently no approved therapies that can reduce the effects of Alzheimer's disease, which affects about 5 million Americans. Each new hit market is expected to earn billions of dollars in sales, according to Reuters.


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