Pharmaceutical companies are eagerly awaiting the opinion of US officials regarding the use of Alzheimer’s drugs. The drug is competitive but, if approved, could be a relatively new treatment for this debilitating disease over many years.
The U.S. Food and Drug Administration is expected to announce Monday whether it approves or disapproves of the Biogen aducanumab drug, which is said to reduce the severity of Alzheimer’s disease.
Why is this important?
If aducanumab is approved, it may be one of the most important decisions the FDA has made over the years. For Alzheimer’s patients and their families they can be commended as revolutionaries in the field of limited therapies and there is no new drug have been approved since 2003.
But the drug, which Biogen co-produced with the Japanese company Eisai, was shattered by controversy, with many saying the drug did not work.
In January, the FDA suspended its decision months later. Pharma advertisers, as well as 6m people living with Alzheimer’s in the US, are just waiting for what the supervisor has to say.
“Undoubtedly this is the largest event in biopharma in 2021,” said Colin Bristow, a researcher at UBS, on the acceptance or rejection of the drug.
How does the drug work?
Aducanumab is an antipsychotic drug administered intravenously to patients with Alzheimer’s disease.
Biogen claims that the drug combines with beta amyloid molecules that form plaques in the brain and disrupt clumps, thereby slowing the progression of Alzheimer’s so that humans can resume daily activities such as cleaning and shopping.
Drug testing “mind amyloid”, Proponents of this theory believe that cerebral palsy causes Alzheimer’s disease.
Howard Fillit, co-founder of the Alzheimer’s Drug Discovery Foundation, called it the “first rigorous test of the amyloid concept”.
What are the possible side effects of these drugs?
Many scientists argue that aducanumab works by following a number of side effects and Biogen clinical trials.
In March 2019, Biogen gave up his two trials an independent committee has ruled that the drug may not be effective. But in October 2020, the company said a new study of large trials showed that the drug worked better when given higher doses.
Biogen was also criticized for research after his experiments were over and some scientists say the data were not enough to be accepted. In November, the FDA advisory team to hit on the findings of the commission “A Thorough Witness” the aducanumab worked.
Caleb Alexander, a professor at the Johns Hopkins Bloomberg School of Public Health, is one of the group’s members.
“I will step down from my seat if he agrees,” he said, adding that the green light “could be one of the most important and worst decisions the FDA has made in recent history.”
Why do so many oppose drug use?
Several medical companies have tried but failed to validate amyloid production and to develop drugs that prevent Alzheimer’s disease. There is no evidence that amyloid removal reduces the severity of the disease.
The only exceptions to the rule were those conducted by Pfizer and Johnson & Johnson in 2012 and Merck’s trials failed in 2017. Last year, Eli Lilly and Roche Both drugs also failed to reduce cognitive decline.
What happens if it is approved?
Accreditation will be appreciated by those with Alzheimer’s disease as a way forward, as well as a testament to the Biogen that has been struggling with criticism of its contribution to the development of the drug over the years.
The Alzheimer’s Association has urged the FDA to approve aducanumab, saying any treatment that gives patients more time is better.
Researchers expect the drug to sell more on Biogen, although accounting rates vary.
Matthew Harrison, head of biotech research at Morgan Stanley, said the need for patients could be high, but some doctors have refused to prescribe aducanumab even if it is approved. “Advertisers are not sure what the meaning of those powerful works means.”
He expects Biogen to earn $ 7bn at a price by 2030 while Bristow of UBS expects an annual increase of $ 18bn worldwide.
“It could be one of the biggest drugs on the market,” Bristow said.
What would happen if it was rejected?
Rejection of aducanumab will knock on people with Alzheimer’s disease who have set their hopes for a slightly lower cure.
More than 6m people in the US have the disease, according to the Alzheimer’s Association, and many cultures have worse during the coronavirus since communication between partners was reduced to reduce the spread of the virus.
Rejection will also be a major problem for Biogen, which has cost millions in the production of these drugs and is lagging behind in some areas. The company’s stock has changed dramatically in response to its previous announcement of the product.
“Aducanumab harmed Biogen for a while because it was a sign of interest in the company, he was left to support genes. [and] new drug approaches, ”says Tom Shrader, chief executive of BTIG.
What does the FDA’s idea mean for other companies?
The green light from the FDA can boost confidence in the concept of amyloid and boost funding in some studies. Eli Lilly is testing donanemab, another drug that removes amyloids, and good news on Biogen should stimulate Lilly’s study interest.
Geoff Meacham, a researcher at Bank of America, said the rejection “is not about putting nails in the death of an amyloid mind box” because the tests Biogen faced are difficult to compare with others. Meanwhile, imaging technology has advanced so that patients can be screened to see if they have amyloid in their brain at first.