With the first FDA approval of a new drug for the treatment of Alzheimer’s disease in nearly 20 years, U.S. biotechnology stocks were boiling overnight. The US Food and Drug Administration (FDA) has approved the experimental drug aducanumab of Biogen for the treatment of Alzheimer’s disease, which will be listed under the name of aduhelm.
Britain pointed out that it is worth noting that aduhelm is the first drug approved to slow the development of Alzheimer’s disease. The drug can clear the sticky clumps formed in the patient’s brain, which some scientists believe lead to Alzheimer’s disease. So far, other approved Alzheimer drugs are designed to treat symptoms rather than slow or reverse the disease process.
Bojian resumed trading after being suspended for nearly three hours on Monday morning. Stimulated by favorable conditions, its share price broke through the two levels of US $300 and US $400 in a row, and the daily increase once reached more than 60%. As of the close, Bojian rose 38.34% to US $395.85. Eisai, a Japanese drugmaker and development partner of the drug aducanumab, also surged 56%.
In addition, driven by this news, the US biomedical sector rose, and the NASDAQ Biotechnology Index rose more than 5% after the news. Among them, Lilly Pharmaceutical (ly) once rose 10%, and the company is also developing an Alzheimer’s disease drug similar to Bojian. The company’s Alzheimer’s disease trial drug data published in the New England Journal of medicine in mid March showed that its drug prospects were good, but not as satisfactory as investors expected.
Dr. Patrizia cavazzoni, director of the FDA Center for drug evaluation and research, said in a press release: we are well aware of the concerns surrounding this approval. We can understand that aduhelm has attracted the attention of the media, Alzheimer’s disease patients, officials and stakeholders. With the treatment of serious and fatal diseases pending, the results of this review deserve a lot of attention.
Despite the encouraging news, the debate over the price of the drug and the lack of evidence of its effectiveness also attracted the attention of the market.
Aducanumab is an intravenous drug. The annual treatment cost is expected to be $56000, much higher than the highest value of $24000 / year expected by analysts. CNBC said the market expected that the approval of the latest drugs would bring billions of dollars in revenue to the company.
There is no doubt about the significance of this drug for Bojian. Colin Bristow, an analyst at UBS, told the financial times that it was definitely a game changing thing for Bojian – the wide range of eligible people was definitely an accident.
However, it should be noted that the FDA’s approval of aduhelm is not completely unconditional, but requires a “phase IV” clinical study. In this regard, FDA said in a press release that the data from two phase III clinical trials in the materials submitted by Bojian are very complex, and there are still uncertainties. Whether aduhelm should be approved or not has long been debated by the public, and experts also have different views.
Some scientists opposed the approval of the drug, saying it didn’t work. Opposing views are not groundless. Aduhelm did not perform well in some trials. According to Bloomberg, in a large trial conducted by Biogen, the drug was generally ineffective. In another similar study, high doses of drugs reduced the rate of disease development by only 22% within 18 months.
Some clinicians are also skeptical about this drug. According to CNBC, some doctors said that due to the mixed clinical data supporting aduhelm, they would not prescribe the drug if it was really on the market.
The Financial Times said the drug was approved through the so-called accelerated approach, which allows the FDA to approve a drug for serious diseases with few treatment options, even before there is conclusive evidence of its effectiveness.
According to the media, Peter Stein, director of the new drug office under the FDA drug evaluation and Research Center, patients are willing to accept uncertainty in order to obtain drugs that can bring obvious benefits in preventing Alzheimer’s disease, because everyone knows that this disease will have devastating consequences.