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Biogen completes filing for highly-anticipated Alzheimer’s drug

FDA has 60 days to decide whether to accept filing for review


Biogen has submitted an application to the US Food and Drug Administration (FDA) for the approval of its controversial Alzheimer’s disease drug, after reviving development of the treatment last year.

It’s been a rocky road for Biogen’s aducanumab – following disappointing results in March last year, Biogen and partner Eisai said they were pulling the plug on the phase 3 testing on the advice of an independent data monitoring committee.

In a surprise twist, Biogen then announced plans to revive the research into the experimental therapy in October, after further analysis of promising results from a subset of patients in the phase 3 EMERGE study.

In the EMERGE trial, data showed that patients who received sufficient exposure to high doses of the drug experienced significant benefits on measures of cognition and function, including memory, orientation and language. The second phase 3 ENGAGE trial, on the other hand, didn’t show clinical efficacy for the drug, with many critics saying that the data is not strong enough to warrant FDA approval.

Although experts have found that the data is complex and hard to interpret, the fact that there are currently no approved treatments for Alzheimer’s on the market could prove to be enough to get aducanumab to the finish line, considering the FDA will be eager to approve new therapies for the mind-wasting disease.

That fact is aptly summed up by GlobalData analyst Alessio Brunello, who suggested the FDA is  “unlikely to turn down aducanumab even if its benefit is modest, given the lack of any therapy that is truly efficacious”.

Now that Biogen has completed the Biologics License Application (BLA) and submitted it to the FDA, the regulatory agency has up to 60 days to decide whether to accept it for review. If accepted, Biogen said it expects the FDA will also inform it whether the application has been granted a priority review designation, which would be a positive signal for the company.

“Alzheimer’s disease remains one of the greatest public health challenges of our time. It robs memories, independence and eventually the ability to perform basic tasks from the people we love,” said Michel Vounatsos, chief executive officer at Biogen.

“The aducanumab BLA is the first filing for FDA approval of a treatment that addresses the clinical decline associated with this devastating condition, as well as the pathology of the disease. We are committed to driving progress for the Alzheimer’s disease community and look forward to the FDA’s review of our filing,” he added.

Biogen is relying heavily on the success of aducanumab, given that Mylan recently won a patent challenge allowing it to manufacture and sell a generic version of the former company’s branded multiple sclerosis treatment Tecfidera.

The company’s spinal muscular atrophy Spinraza (nusinersen) is also facing increasing competition from the likes of new therapeutics that include Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec) and Roche’s investigational therapy risdiplam.

Article by
Lucy Parsons

9th July 2020

From: Regulatory



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