Health
FDA approves drug for Alzheimer’s disease in response to internal objection
3 FDA Advisory Board members He resigned in protest of drug approval. Other critics have warned that high costs can overwhelm the healthcare system, coupled with expensive diagnostic procedures and the need for regular screening of patients taking medication. Nearly 6 million Americans have Alzheimer’s disease.
They said: “The primary statistical review does not recommend approval,” an FDA neurology official wrote in a memo dated June 7 summarizing the recommendations of government statisticians. These statisticians made decisions based on two major clinical trials of the drug. One showed a positive result and the other showed a negative result. “This creates a contradiction between one positive study and one negative study,” the memo said.
FDA statisticians refused to reanalyze the data by Biogen, and a second trial showed that it was effective if it was continued for a long period of time rather than being discontinued due to lack of efficacy. I suggested that.
Top executives disagreed: But a document released Tuesday tells Aduhelm, based on limited data, by senior FDA officials, including FDA director Patrizia Cavazzoni, new drug director Peter Stein, and neuroscience director Billy Dunn. It shows that it supported the decision to give accelerated approval, suggesting that it reduces the level of amyloid plaque in the brains of patients with Alzheimer’s disease.
Amyloid plaque accumulation is a marker of disease, but doctors and scientists have no evidence that reducing or preventing protein accumulation can alleviate a patient’s symptoms.
“I do not agree [the Office of Biostatistics’] “Recommendation that the application should not be approved,” Cavazzoni wrote in a note on June 7. “I agree … [drug] Biogen provided substantial evidence of its effectiveness at surrogate endpoints of reduction of amyloid plaques in the brain, and surrogate endpoints are much more likely to predict clinical benefit, with expedited approval. Meets the requirements.
Other FDA executives discussed Biogen’s application at a meeting on April 26, with Peter Marks, director of biology, Richard Pazdur, director of the Center of Oncology of Excellence, and Issam, director of the clinical pharmacology office. Zineh, and Jacqueline Corrigan-Curay, director of the medical policy office, have approved the accelerated approval approach. ..
Labeling Expectations: The FDA eventually turned a green light on Biogen’s drug for all Alzheimer’s disease patients without contraindications — disagreeing with Stein’s expectations in his June 7 note in favor of accelerated approval. A decision that looks like.
He wrote that the drug was most likely to benefit people in the early stages of the disease, and appeared to assume that FDA approval would limit the use of the drug to those patients.
“AD is a progressive disease, which means patients who are eligible to be treated with this drug under AA if access is delayed for several years. [accelerated approval] It can suffer from irreversible loss of brain neurons and cognitive function and memory, “Stein said. “In addition, there may be a” window “for profit. As a result, patients who progress to the later stages of the disease in the next few years may be disqualified from treatment if they are found to provide clinical benefit. It is indicated for patients relatively early in the clinical course. “
What’s next: Medicare Medicaid Service Centers and private payers are faced with the pressure to decide under what circumstances to cover a patient’s medication.
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