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BIogen staged a vigorous defense of his controversial Alzheimer’s drug on Thursday, with Aduhelm, the company’s head of research and development, issuing an open letter to the Alzheimer’s community aimed directly at criticism of the approval.
Al Sandrock, chief R&D officer and architect of many of Biogen’s successes, wrote that the letter’s purpose was to correct “misinformation” about the drug.
“Unfortunately, Aduhelm’s endorsement has been the subject of a lot of misinformation and misunderstanding,” Sandrock wrote. “It is normal for scientists and clinicians to discuss data from clinical experiments and trials, debate and disagree on the interpretation of the data. This is how science moves forward and we welcome these discussions. Recently, however, there has been a turning point outside the bounds of legitimate scientific deliberation. “
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The company’s chief executive, Michel Vounatsos, echoed the comments during a call with investors. “I want to be clear that Biogen supports the integrity of the review process,” Vounatsos said. He said he understood concerns about the drug’s $ 56,000 price tag and promised to make sure patients could receive it.
Biogen also on Thursday reported higher than expected sales of $ 2.78 billion in the second quarter, down 25% from a year ago, in part due to a 24% drop in sales of the company’s flagship multiple sclerosis drugs. The company earned $ 448 million in the quarter. Earnings per share excluding unusual items was $ 5.68, 25% higher than forecast by investment analysts polled by FactSet.
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Sales of Aduhelm, which was approved on June 7, totaled $ 2 million.
In his letter, Sandrock commented on much of the fury that surrounded the Alzheimer’s drug, which critics say should not have been approved because they believe its clinical trials do not show that the drug benefits patients. A panel of experts from the Food and Drug Administration had previously voted that the drug should not be authorized. Several FDA panelists have resigned to protest the approval. There was also a drop in the price of the drug.
STAT last month reported on unusual meetings between the FDA and Biogen and the company’s efforts to use back doors in the fight for drug approval. Janet Woodcock, the acting commissioner of the FDA, called the independent office of the inspector general to investigate how agency staff interacted with Biogen.
“We welcome a formal review of interactions between the FDA and Biogen on the path to aducanumab approval,” Sandrock wrote. “A better understanding of the facts is good for everyone involved to ensure confidence in both the therapy and the process by which it was approved as we prioritize the issues that affect patients. “
He then went on to address several points that he characterized as misinformation. First, he pointed out, the fast-track approval path used to approve Aduhelm is not new and has been used over 250 times, implying that using Aduhlem was not unusual. However, he did not respond to more specific criticisms, such as the fact that the FDA did not previously consider removing amyloid plaque, which is found in the brains of Alzheimer’s patients, such as “reasonably likely” to show a benefit, the standard for expedited approval. . Sandrock wrote that he believes Aduhelm’s approval will be “established”, but did not provide a timeline for a follow-up study.
Scientists disagree on whether removing amyloid plaque is likely to mean that a drug is working. In his letter, Sandrock also addressed this issue.
“Several people have stated that all of the anti-amyloid antibodies previously studied remove amyloid from the brain but have failed as a class to demonstrate a benefit,” he wrote. “This is factually incorrect. These earlier antibodies, Sandrock pointed out, “do not remove amyloid from the brain.” However, the FDA used a review of previous antibody studies in patients with reduced cerebral amyloid as part of its rationale for approval.
The studies that led to Aduhelm’s approval were initially halted because the company believed they couldn’t be successful, but Biogen later found out that one seemed successful and the second didn’t. Sandrock wrote that critics said the results are “post hoc” – a scientific term that means the results were analyzed after the fact and are therefore likely invalid. He pointed out that the studies used their predetermined measures of success.
However, statistical reviewers from the FDA, who opposed the drug’s approval, repeatedly wrote in memos released by the agency that some of Biogen’s tests, including those it used for claim that his failed study also supported efficacy, were post hoc.
Sandrock also defended the close working relationship between the FDA and Biogen.
“It is important to recognize that collaboration between industry and regulators is common, appropriate and beneficial,” he wrote. “This has been illustrated at its best with the development of the COVID-19 vaccine. As a physician, scientist, and head of research and development at Biogen, I believe scientists from regulatory agencies and drug manufacturers need to work together to tackle other devastating threats to public health.
Sandrock acknowledged that the data on Aduhelm are “complex” and that the drug has not followed “a conventional path”. He wrote: “But the path to innovation is rarely straightforward, and Aduhelm is no exception.
“The letter does not replace a report of trial data in peer-reviewed academic literature,” said Samuel Gandy, professor at Mount Sinai Hospital in New York City. “Doctors alone determine if and if so how to use this drug. The label offers almost no guidance. The least the company can do is publish the test results so that all stakeholders can see not only all the data, but all the same data. “
In a vivid exchange on the call, Jay Olson, investment analyst at Oppenheimer, asked why the media had mounted such an “assault” on Aduhelm.
“It appears that since March 2019, Biogen has been the target of constant assault from the media and other groups, which obviously escalated on June 7, when Aduhelm was approved,” Olson said. “What do you think there is about Alzheimer’s disease that causes the media to react so negatively to a drug that could actually help patients and their families and not treat them with the same respect that is shown? rightly to the victims of other diseases such as cancer? “
“You are absolutely right in your question and your description of what we are exposed to,” Vounatsos replied. “But we are not the ones who suffer the most. We are still only in the early days of the launch. It is still the beginning. And whatever the grounds for the controversy, those who are potentially misled, confused and deprived of help are the patients. “
He then argued that past experience in areas such as HIV indicates that this type of early approval can lead to more competition and, later, greater payoff for patients.
One of the resigned FDA panelists, Aaron Kesselheim, director of a program that studies regulation at Brigham & Women’s Hospital, wrote in his resignation letter that part of his objection to the approval was the “Questionable premise” that amyloid suppression is likely to help Alzheimer’s patients.
Analysts focused on another set of data: whether medicare plans and the government medicare program will pay for the drug. Medicare takes an unusual step, called determining national coverage, to decide whether and for whom to pay for the drug.
Biogen said 900 sites will be ready to offer infusions of Aduhelm – the drug is to be administered intravenously – shortly after approval. Of those 900, the company said 35% either completed a positive review by a pharmacy and therapeutics committee, which determines whether a drug will be administered, or said it would not be needed. Two large hospitals, the Cleveland Clinic and Mount Sinai Medical Center, have said they will not offer Aduhelm. The company also said it expects Medicare Advantage plans, a form of Medicare built around private insurance, to cover the drug until the process of determining coverage is complete.
This story has been updated with outside commentary, more details on Biogen’s appeal to investors and Aduhelm’s insurance coverage.
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