Biogen’s controversial Alzheimer’s treatment, aducanumab crossed a crucial threshold of approval just to save the business.
On Monday, regulators in the US approved aducanumab (of Biogen) as the first treatment to address an underlying cause of Alzheimer’s disease. The approval came despite controversy over mixed clinical trial results for the drug.
The Alzheimer’s disease (AD) is a progressive neurological disorder that causes the brain to shrink (atrophy). It leads the brain cells to die. Production & deposition of beta-amyloid peptide drives ahead the progression of Alzheimer’s disease.
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Aducanumab aims to remove sticky deposits of this protein- beta amyloid from the brains of patients in earlier stages of Alzheimer’s. The removal of beta amyloid helps in staving off its ravages, which include memory loss and the ability to care for one’s self.
The treatment of aducanumab would be sold under the brand name-Aduhelm.
US Food and Drug Administration said that the clinical trials for Aduhelm, showed a reduction in the plaques that is expected to lead to a reduction in the clinical decline of patients.
In a statement, USFDA said, “Although the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patient.”
The approval is set to cause a domino effect among pharmaceutical-companies and researchers studying the elusive disease-AD. It is worthwhile to note that AD is the sixth leading cause of death in the U.S. The approval comes after months of intense controversy over whether Biogen’s Alzheimer’s treatment actually helped to counter cognitive decline. Biogen has placed all of its cards on aducanumab, now marketed as Aduhelm. This comes amid serious troubles elsewhere in its business. Multiple sclerosis drug Tecfidera and spinal muscular atrophy med Spinraza are other drugs of Biogen. They have been facing increasing competitive pressures, leading the company to post a sales-decline in 2020.
Aducanumab had been hailed by patient advocates. Some neurologists are eager to have an effective option for patients with the lethal disease. Other doctors said that clinical trial results of aducanumab were inconsistent and more proof was needed.
USFDA said that Biogen must conduct a post-approval clinical trial to verify the drug’s clinical benefit.
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Biogen’s Aducanumab was studied in patients with early AD who tested positive for a component of amyloid brain plaques. On a concerning side, some of the trial patients experienced potentially dangerous brain swelling.
As per an estimate of Biogen, around 1.5 million Americans would be eligible for treatment with aducanumab. The drug is given by monthly infusion, raising concerns about costs to the healthcare system.
Biogen’s Aducanumab is a monoclonal antibody (MAB) designed to break down the buildup of amyloid plaque that is thought to worsen AD.
The approval is a sure win for patients and advocacy groups lobbying for the green light for Aducanumab, as well as Biogen and its Japanese pharma partner Eisai.
