FDA Trims Use of Contentious Alzheimer’s Drug Amid Backlash – NBC 5 Dallas-Fort Worth

A month after a controversial new Alzheimer’s drug was approved, U.S. health officials signed new prescribing instructions Thursday that are likely to restrict its use.

The Food and Drug Administration said the change is intended to remove confusion among doctors and patients about who should be given the drug, which has seen violent public backlash since it was approved last month.

The new drug label emphasizes that the drug Aduhelm is suitable for patients with mild symptoms or early Alzheimer’s disease, but has not been studied in patients with advanced disease. This is a big change from the FDA’s original instructions, which simply stated that the drug had general approval for Alzheimer’s disease.

Drug maker Biogen announced the change in a press release on Thursday, stating that the update is intended to “educate” the patient population investigated in the company studies that led to approval. The FDA first reached out to the company to restrict the label and confirm the language.

“Because of these concerns, the FDA decided that the prescribing information could be clarified to resolve this confusion,” the agency said in a statement it emailed. Despite the update, the FDA added that “some patients may benefit from ongoing treatment” if they develop more advanced Alzheimer’s disease.

When the drug was first approved, a senior FDA official told reporters that the drug was “relevant to all stages of Alzheimer’s disease.”

The FDA’s OK last month quickly sparked controversy over Aduhelm’s $ 56,000-a-year price tag and its questionable benefits. Three outside FDA advisors resigned because of the decision. Harvard researcher Dr. Aaron Kesselheim called it the “worst drug approval decision in recent US history”.

On Thursday, Kesselheim tweeted the change was “a welcome move,” but added that the FDA and Biogen should do a lot more to combat “misperceptions about this drug.”

Far-reaching changes to drug labels are rare, especially just a few weeks after approval.

“It is a responsible move by both the FDA and Biogen to maximize safety while giving the drug the best chance of working,” said Dr. Ronald Petersen of Mayo Clinic, who has advised Biogen and other drug manufacturers. Side effects of the drug include brain swelling and bleeding.

Aduhelm has not been shown to reverse or significantly slow the disease. But the FDA said its ability to reduce plaque clumps in the brain is likely to slow down dementia. Many experts say that there is little evidence to support this claim.

Biogen needs to do a follow-up study to definitively answer whether the drug is slowing mental decline. Other Alzheimer’s drugs only provide temporary relief from symptoms.

Given the price and widespread approval, some analysts fear that Aduhelm could add tens of billions of euros in new spending to the US healthcare system, particularly the federal government’s Medicare program. Alzheimer’s affects approximately 6 million Americans, the vast majority of whom are old enough to qualify for Medicare.

Two congressional committees in the House of Representatives have opened an investigation into the FDA’s review of the drug. And Senate lawmakers have called for hearings on the drug’s cost and impact on federal spending.

The tighter label can allay some of these concerns by reducing the number of patients likely to receive the drug, which requires monthly IV infusions. Many hospitals have already announced that they will limit the use of the drug to patients with earlier stages of the disease. Doctors could still prescribe the drug to more advanced patients, although insurers might refuse to pay for it, citing the FDA label.

“It was quite disturbing that the previous label was so diversified, encompassing patient populations who had never tested the drug,” said Dr. Suzanne Schindler from Washington University in St. Louis. “I think this is a positive change because it better reflects the patients in whom the drug has actually been studied.”

Wall Street analysts said the change would not materially affect Biogen’s forecast sales. Jefferies’ Michael Yee said in a research note that the company was already planning to use the drug for the 1 million to 2 million Americans with mild Alzheimer’s disease.

___

Follow Matthew Perrone on Twitter: @AP_FDAwriter

___

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

[ad_1]