July23 , 2021

Biogen blames ‘misinformation’ for cloud over its Alzheimer’s drug



Biogen has issued a staunch defence of the science and approval course of behind its controversial Alzheimer’s drug, saying that “misinformation” is fuelling criticism of the therapy.

The pharmaceutical firm has confronted mounting scrutiny following the approval of its Alzheimer’s drug final month by the US Meals and Drug Administration.

Michel Vounatsos, chief government of Biogen, stated in an earnings name on Thursday: “I wish to be clear that Biogen stands behind the integrity of the evaluation course of.”

The therapy, which is bought below the model identify Aduhelm, “was authorized appropriately on very stable grounds and represented the fitting factor to do”, he stated.

Some scientists have stated the therapy doesn’t work and may by no means have been given the go-ahead, whereas others allege that the US medicines regulator and the drugmaker had collaborated too intently within the run-up to the approval.

The $56,000-a-year infusion therapy is the primary Alzheimer’s drug to be given the inexperienced gentle in almost 20 years. Biogen claims the drug is the primary to deal with the causes of the debilitating illness, reasonably than simply serving to sufferers handle their signs.

Earlier this month the appearing head of the FDA took the bizarre step of calling for an unbiased investigation into the company’s interactions with Biogen executives as questions mount over why the drug was authorized.

Michael McDonnell, Biogen’s chief monetary officer, stated the Massachusetts-based drugmaker welcomed the formal evaluation and that it could be “good for everybody concerned to make sure confidence within the remedy”.

Biogen stated revenues from Aduhelm hit $2m within the second quarter, however Vounatsos famous {that a} “massive chunk” of the gross sales had been stock and didn’t reveal the variety of sufferers who’ve began therapy.

McDonnell defended the drug towards a number of claims that he known as “factually incorrect”, together with that decreasing amyloid plaques within the mind doesn’t end in slowing the progress of Alzheimer’s illness.

Aduhelm is designed across the amyloid speculation, whose proponents say that clumps of protein increase within the mind trigger Alzheimer’s.

Quite a few pharmaceutical firms have beforehand tried and didn’t develop amyloid-clearing medicine and show that eradicating the proteins can mitigate the illness.

“There isn’t a foundation for utilizing the failure of those antibodies as a cause to not approve [Aduhelm],” stated McDonnell, who stated there was no proof that these different remedies really eliminated amyloids.

He additionally stated claims that the corporate carried out publish hoc evaluation had been factually incorrect. Biogen’s scientific trials had been initially halted in March 2019 after an unbiased committee discovered that the drug was not going to be efficient. The corporate later offered new evaluation saying the therapy was profitable when taken at a better dose.

McDonnell stated individuals who believed approval of the drug would result in much less funding into analysis for different Alzheimer’s remedies had been “contradicted by precedent”, citing the historical past of analysis into HIV and a number of sclerosis.

Biogen’s second-quarter gross sales fell 25 per cent in contrast with the identical interval final yr, to $2.8bn. Analysts had anticipated earnings of $2.6bn, in line with FactSet.

Shares in Biogen rose 1.4 per cent in morning buying and selling on Thursday in New York.