The fate of Eduhlem, the company’s controversial Alzheimer’s drug In Eugene, Decided this week: Medicare, the US government insurance company that insures most people aged 65 and over in the US, has finally decided not to cover the drug for its policyholders until Biogen completes a Phase IV trial (clinical trial for a drug already on the market) that will show efficacy Of the product in patients.
Against this background, it was more or less decided to eliminate the product. Most of the product sales team will be fired, and with them will also go home Biogen CEO Michael Wentso. Can the CEO be blamed for taking the opportunity given to him by the FDA (US Food and Drug Administration) to launch a drug even if the clinical information behind it Was unequivocal? Or is only the regulator to blame? In the end, the launch of the product was a fiasco, and Eugene did not read the market correctly. So apparently the responsibility is indeed on the CEO as well. Biogen’s value now stands at $ 28 billion, and the share price has dropped 28% compared to the day before the announcement of the unnecessary retroactive approval.
Now the question arises – what next for Biogen in general, and its Alzheimer’s program in particular?
Summary of previous episodes: In June 2021, the FDA decided to approve the drug even though the Director’s Advisory Committee ruled that the experiment conducted by the company was not sufficient for approval. The decision was widely criticized and even led to the resignation of three committee members, but the FDA did not back down from its decision, opening the door to the market for Biogen.
Biogen’s drug approval was given even though the company failed to demonstrate in its clinical trial a slowdown in Alzheimer’s disease, but only in retrospective analysis of the results, after the drug had already been declared a failure.
Revenue of only $ 3 million in 2021
After the approval and audit, a female at a very high price in Eugen, $ 56,000 a year, and the audit of the approval itself was joined by criticism that the need to fund this drug would collapse Medicare. The FDA defined Biogen’s approval as “conditional approval for further trials,” but when asked when it would conduct those trials, the answer was not “as soon as possible,” but “later.”
Against this background, Medicare as aforesaid refused to language the drug until the further experiment was carried out. Adohlem’s revenue in 2021 was only $ 3 million.
Biogen has announced that the liquidation of the Adohlem program will save the company $ 500 million a year and it will invest them in, among other things, another Alzheimer’s product called Lecanemab. This is also a product that was jointly developed by Biogen with a smaller company from it called Esai. This time the deal with the regulators will be carried out by Asai, and not by Biogen. This is an unusual move, in which the smaller company, and another non-American company, is considered the preferred partner for dealing with the FDA. Results from a Phase III trial of the drug are expected in the last quarter of the year, and if this product proves effective in patients, it may be approved as early as 2023. Then Alzheimer’s patients will also really have hope, instead of more worries.
More companies will need to reconsider their steps
This change affects the entire field of Alzheimer’s. The FDA’s decision was based on the PA’s controversial scientific approach that removing a substance called amyloid beta plaque from the brain means treating Alzheimer’s, although not the whole market accepts that plaque removal does lead to disease improvement, and Eugene has not really succeeded. Show this in her experiments. Against this background, other companies have decided to submit products for approval, based on their ability to reduce plaque, without being required to go through the long, expensive and uncertain process of an experiment designed to demonstrate real improvement in the clinical symptoms of the disease.
Now, after the chilling reaction to this type of drug on the market, both companies competing in this field and the FDA, will have to re-market whether there is any point in approving a drug that has only proven plaque reduction. It seems that the market, i.e. mainly insurers and also most doctors, is not willing to accept such a product without further proof. Something has fallen in the biotech market, according to which the insurer is much stronger than the FDA, in deciding what standard of proof is required for a drug to enter the market. The new drug that Biogen is building on is also based on the amyloid hypothesis, so its regulatory pathway is less clear today than in the past.
“The story of the beta amyloid is still evolving,” Wentos said upon his departure. “This story will continue.” He seems to be hoping that the additional products in the category will retrospectively justify this scientific approach, in a way that will retrospectively save his reputation as well.