In Reversal, FDA Calls for Limits on Who Takes Alzheimer’s Drugs

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Under fire for approving a questionable drug for all Alzheimer’s‘s patients, the Food and Drug Administration on Thursday largely narrowed down the previous recommendation and now recommends that only those with mild memory or thinking problems should take it.

This turnaround, quite unusual for a drug that has only been on the market for a few weeks, is likely to reduce the approximate number of Americans eligible for treatment from six million to 1.5 million.

approval aduhelm Earlier last month, it was one of the most controversial FDA decisions in years. Groups representing Alzheimer’s patients lobbied heavily with the institution to sign the first new drug in 18 years to treat the disease and the first drug designed to attack its biological bases.

But many the FDA’s independent advisory committee, as well as scientists, said there is no convincing evidence that the drug works.

In addition, the agency’s recommendation that Aduhelm be open to all Alzheimer’s patients, not just those with early symptoms, has stirred things up. even more worries among medical professionals, including those who support the drug’s approval.

Three members of the advisory board after approval resigned in protest. One, Dr. Aaron Kesselheim described it as the “worst approval decision” he can remember.

Biogen, the drug’s manufacturer, said last month that it will charge $56,000 annually for the drug. As side effects of the drug include brain swelling and bleeding, associated costs such as diagnosis and safety monitoring can add tens of thousands of dollars to each patient’s annual bill.

Analysts had expected widespread use of the drug to strain Medicare’s budget. By a guessThe $29 billion in new spending, which is more than the annual budget of the National Aeronautics and Space Administration, could put taxpayers in a tight spot.

The new guidance does not prevent doctors from prescribing Aduhelm to people with moderate or severe Alzheimer’s. But face-to-face sends a strong message to doctors and insurers about who should take the drug.

It also significantly increases the likelihood that Medicare and private insurance companies will restrict coverage of the drug given as a monthly intravenous infusion. This means that people with moderate or severe Alzheimer’s often have to pay out-of-pocket five-figure annual expenses that experts think are unlikely to happen.

FDA spokesman Michael Felberbaum said the agency changed its recommendation after “confusion about the intended population for treatment”.

Biogen’s head of research and development, Dr. Al Sandrock said in a statement that the company is “committed to continuing to listen to the needs of the community” regarding Aduhelm. Biogen’s stock has risen 29 percent since the drug was approved on June 7.

When Biogen ran clinical trials of Aduhelm, they only included people with early signs of cognitive decline. The drug appeared somewhat effective at best.

In one late-stage trial, the highest dose of the drug slowed patients’ cognitive decline by a fraction of an 18-point point. scale evaluate their memory, problem-solving skills and functions. But in a second similarly designed clinical trial, the drug showed no benefit.

The FDA approved the drug under a framework known as accelerated approval. This allows for drugs that haven’t yet shown that they can help patients approve if they have a significant impact on the biomarkers of a disease.

The agency admitted last month that there is no convincing evidence that Aduhelm slows patients’ cognitive decline. Instead, he based his approval on the drug’s ability to lower levels of a protein called amyloid, which builds up in plaques in the brains of Alzheimer’s patients.

But many Alzheimer’s experts said there is no solid evidence that lowering amyloid levels has any effect on people’s cognitive problems.

At a forum sponsored by the Alzheimer’s Association, which pushed for approval of Aduhelm last month, a panel of clinicians with differing views on whether the drug should be approved converged, saying its use should be limited. The consensus was that Aduhelm should only be for patients in mild stages of the disease who have high levels of amyloid in their brain and do not have medical conditions that could make them vulnerable to the potentially dangerous side effects of Aduhelm.

On Thursday, director of the California Alzheimer’s Disease Center at the University of Southern California, Dr. Lon Schneider said the FDA needs to further narrow down the guidelines listed on the drug’s label on who is eligible for the drug.

Working on one of Aduhelm’s clinical trials and opposing its approval, Dr. The trials excluded people with diabetes and high blood pressure and taking blood thinners, Schneider said. As a result, “we don’t know of any increased risk for these patients,” he said, adding that the drug’s label should include warnings about treating these patients with Aduhelm.

FDA interim commissioner Dr. It is led by Janet Woodcock because President Biden has not nominated a permanent leader. Before becoming an interim commissioner in January, Dr. Woodcock was the longtime leader of the agency’s arm responsible for approving drugs. Authorities said they were not involved in Aduhelm’s decision, but defended the decision as “very firm”.

Some experts said the FDA’s quick turnaround was a sign that it mishandled its initial review and is now getting close to where it needs to start.

Co-director of the University of Pennsylvania Penn Memory Center, Dr. “This revision of the label is yet another piece of evidence that should cause the American public to worry about how the FDA is applying its regulatory science,” said Jason Karlawish.

The fallout from the drug’s initial approval is still spreading.

In Congress, two House committees last month announced an investigation To Aduhelm’s approval and price. Senators from both parties have called for an investigation in this parliament.

This type of external scrutiny is important because of the controversy surrounding the drug and the FDA’s decision-making process, the researchers said. Dr. “This event heightens the importance of holding these congressional hearings to understand what’s going on at the FDA and why they’re doing it,” Karlawish said.

Some analysts said the narrower eligibility for the drug could help Biogen deflect criticism from lawmakers. “It helps their cases say, ‘Hey, we’re not pushing the boundaries as completely as we can,'” said Brian Skorney, an analyst at Robert W. Baird & Company. He said Aduhelm expects to generate $7.5 billion in revenue for Biogen by 2025.

Biogen has yet to disclose how many patients are taking the drug, but its distribution is expected to slow in the first months due to difficulties in its administration.

The FDA’s narrowed guide only applies when people start taking the drug. Spokesperson Mr Felberbaum said some patients at Aduhelm whose symptoms worsen “may benefit from continued treatment”.

The point to note is that there is no scientific evidence that Aduhelm will help such people.

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