Approved by the Food and Drug Administration on Monday BiogenAducanumab, a treatment for Alzheimer’s disease, was the first drug approved by US regulators to delay cognitive decline in patients with Alzheimer’s disease and was the first new drug in nearly 20 years.
The FDA’s decision was highly anticipated. The drug, sold under the name Aduhelm, is expected to generate billions of dollars in revenue for the company. It provides new hope for patients’ friends and family who live with their illness.
Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release: “We understand that Aduhelm is in the spotlight of the press, the Alzheimer’s disease community, elected officials and other stakeholders.”
“Given the treatment of serious and life-threatening illnesses, it’s not surprising that so many people followed the results of this review,” Cavazzoni added.
The FDA said it would continue to monitor drugs entering the US market. The agency has granted approval on the condition that Biogen conducts another clinical trial.
Alzheimer’s disease is a progressive neurodegenerative disorder that gradually destroys memory and thinking.According to, more than 6 million Americans live on it Estimated by Alzheimer’s Association. By 2050, that number is projected to grow to nearly 13 million.
No drug has previously been approved by the FDA that can delay the psychological decline caused by Alzheimer’s disease. Alzheimer’s disease is the sixth leading cause of death in the United States. The agency has approved a drug for Alzheimer’s disease that aims to help the symptoms rather than actually delaying the disease itself.
Federal regulators have faced strong pressure from friends and family members of Alzheimer’s disease for rapid tracking of aducanumab, but the path to regulatory approval has been controversial since it was seen as promising in 2016. ing.
In March 2019, Biogen discontinued research on the drug after an independent group analysis revealed no potential effect. A few months later, after all, the company shocked investors by announcing that it would seek regulatory approval for the drug.
Biogen’s share surges in November After getting support from FDA staffHe stated that the company provided very “convincing” evidence that aducanumab was effective and had an “acceptable safety profile to support its use in patients with Alzheimer’s disease.”
But two days later, a panel of outside experts U.S. agency unexpectedly refuses approval An experimental drug, citing unconvincing data. He also criticized the agency’s staff, called overly favorable reviews.
When Biogen sought approval for the drug in late 2019, scientists said a new analysis of a larger data set showed that aducanumab “reduced the clinical decline in patients with early-stage Alzheimer’s disease.” Said.
Alzheimer’s disease experts and Wall Street analysts are quickly skeptical that approval will enroll patients in their drug trials to see if clinical trial data are sufficient to prove the drug’s efficacy. I wondered if it would make it difficult.
Some doctors Said not to prescribe If the drug hits the market because of a mix of data packages that support the company’s applications,
Proponents, including advocates and families struggling for new treatments, admit that the data are incomplete. But they are one of Alzheimer’s diseases, a progressive and debilitating disease. Claims that it may be useful for patients in the department.
Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, and scientists predict it will be involved in this catastrophic disease, according to Reuters. So far, it has been estimated that about 1.5 million people with early-stage Alzheimer’s disease in the United States may be candidates for the drug.
Brian Abrahams, an analyst at RBC Capital Markets, said in a June 1 customer note that the FDA’s decision is expected to impact the entire biopharmacy sector.
A US agency said Monday that it had determined that the drug had “substantial evidence” to help patients.
Biogen’s Alzheimer’s disease treatment approved by FDA, new treatment for the first time in almost 20 years
Source link Biogen’s Alzheimer’s disease treatment approved by FDA, new treatment for the first time in almost 20 years