Bojian Aducanumab is about to usher in trial!

Text | pharm_rookie

June 7th, US time, is the deadline for the FDA to decide whether to approve Biogen's Alzheimer's drug Aducanumab.

As one of the most difficult medical challenges of this era, the research and development of Alzheimer's drugs has been on the most difficult road, and the development of Aducanumab is also full of hardships and doubts.

01 Only a few drugs have been approved for decades, and the treatment of Alzheimer's disease has been stagnant

Alzheimer's disease (AD) refers to degenerative diseases of the central nervous system that occur in old age and pre-senility and are characterized by progressive cognitive dysfunction and behavioral impairment

Correspondingly, the FDA has approved several cholinesterase (AChE) inhibitor drugs for alleviating patients’ related symptoms since 1993, although scientific research so far has not fully proven that cholinesterase inhibitors are effective for treatment.

Picture from NIH official website

In November 2019, the drug Mannote Sodium Capsules (trade name: Phase 1) developed by Green Valley Pharmaceuticals was approved for marketing in China.

02 Mechanism hypotheses are emerging one after another, and various pharmaceutical companies have made efforts

Since the pathogenesis of Alzheimer's disease has not been fully studied yet, the development of most new drugs has also announced "breaking down the sand"

According to incomplete statistics, the failure rate of new drugs for Alzheimer's disease is as high as 99.

In January 2018, Pfizer announced that it would stop the discovery and research of Alzheimer's disease and Parkinson's treatment drugs.

In June 2018, Eli Lilly and AstraZeneca jointly announced the termination of the Phase III clinical study of the BACE inhibitor Lanabestat.

In 2019, Roche announced the failure of two phase III trials of Crenezumab in the treatment of AD because Crenezumab may not reach the primary endpoint of improving the clinical dementia comprehensive rating scale (CDR-SB score);

In January 2021, Biohaven Pharmaceuticals announced that its EAAT2 inhibitor Troriluzole had once again failed in a phase II/III clinical study for the treatment of mild to moderate Alzheimer's disease

Despite failures time and time again, in the face of huge gaps in the drug market and huge profit margins in the future, there are still one after another "adventurous players" joining the track one after another

Due to the miserable failure of many drugs on the amyloid cascade hypothesis, the industry has gradually turned its attention to Tau protein and more mechanisms of action

Statistics show that there are at least 50 million Alzheimer's disease patients in the world, and it is expected to reach 150 million by 2050

The picture is compiled from the drug clinical trial registration and information disclosure platform

03 After Alzheimer's disease drugs are marketed, there are still many obstacles

According to reports, after the launch of Phase Nine, a single box of drugs is priced at 895 yuan, the monthly cost of medication is 3580 yuan (calculated on a 28-day basis), and the annual medication cost is about 40,000 yuan.

Similarly, Aducanumab’s pricing has also encountered certain controversy and resistance.

In academia, Aducanumab and Phase 9 have also been greatly questioned.

For patients, in addition to the potentially high cost of the drug itself, the PET scan and cerebrospinal fluid amyloid test used in the treatment of Aducanumab are currently not covered by U.
S.
medical insurance.
In addition, patients need to be followed up regularly during Aducanumab treatment.
As well as monitoring, it is also a big challenge to the current medical system
.

As one of many Alzheimer's disease treatment drugs in the development process, Aducanumab is undoubtedly lucky.
It has reached the final stage, and it also brings a profound effect to the development of Alzheimer's disease drugs in the future.
Thinking
.
How to deal with the industry's doubts, high drug prices, and adapt to the existing medical system are all issues that need to be resolved urgently after the launch of Alzheimer's drugs
.
It is not easy for Alzheimer's drugs to be marketed.
Don't let all the efforts made in the previous decades be wasted because of various problems after the market
.