FDA likely to approve Biogen’s Aducanumab after its review

Following the release of FDA documents today noting support for the safety and efficacy of Biogen’s treatment for Alzheimer’s Disease (AD), aducanumab, it is looking very likely that the drug will become the first new AD therapy to be approved in 17 years. If it is approved, the drug could be in the market by March 2021, notes GlobalData, a leading data and analytics company.

Alessio Brunello, Managing Pharma Analyst at GlobalData, comments: “Even before this positive response, GlobalData expected global sales of Biogen’s aducanumab to be high – equating $4.1bn in 2028 across the eight major markets (8MM*). There are currently no disease-modifying therapies (DMTs) for this indication – and no close competitors in the late pipeline – offering aducanumab a huge advantage. The drug’s potential approval will only strengthen Biogen’s position, with nod to that its shares surged 40% to $354.25, adding $17bn to the company’s market value.”

Key opinion leaders (KOLs) interviewed by GlobalData expressed mixed opinion about the potential approval from the FDA, noting that the cumulative data around efficacy and safety for aducanumab are not substantial enough to meet the FDA’s standard. This concern was also expressed by a few FDA reviewers, which asked for an additional trial to confirm the evidence of aducanumab in slowing the disease. However, KOLs believe that the FDA is unlikely to turn down aducanumab – even if its benefit is modest – given the lack of any therapy that is truly efficacious in the space.

Brunello continues: “There is a high unmet need for DMTs in AD, as the current competitive landscape comprises six medications that are only aimed at treating the symptoms of disease. KOLs interviewed by GlobalData indicated that, due to the lack of DMTs, any agent that can reverse or stop the underlying pathology of the disease will become a key therapy in disease management.

Among decisions being made Friday, when the FDA comes to its final decision on the drug’s approval, is whether aducanumab’s solution for intravenous infusion will attain its biologics license.

Brunello adds: “Aducanumab’s  infusion route of administration could be an issue where infusion centers aren’t available and concerns regarding the developing of amyloid-related imaging abnormalities (ARIA) can represent a barrier for the drug’s uptake. Physicians will also will be obliged to perform regular MRI scans on patients to see if they have ARIA reactions, which could serve as a limitation from an economic point of view.”

*8MM: US, France, Germany, Italy, Spain, UK, Japan and China

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