Bojian Alzheimer's Disease New Drug Regeneration Waves!

Bojian's new Alzheimer's disease drug Aduhelm has been approved for marketing, and the focus is on the FDA this time
.
Two US Congressional Democrats asked the FDA to provide more data and documents to support the previous approval of the drug

The two congressmen’s doubts were based on a report released by Star News in June, which stated that Bojian and the FDA had communicated as early as 2019, and Bojian had had many unofficial meetings with FDA executives
.
The report also pointed out that on July 23, there was a previously unreported meeting between FDA staff and the advisory committee

In addition, the two lawmakers asked the FDA to provide detailed information on all formal and informal meetings with Bojian, as well as the reason why the FDA approved Aduhelm for a wider range of indications, but then narrowed the scope of the indications
.
At the same time, the two lawmakers also asked the FDA to provide background information on Aduhelm's fourth phase confirmatory trial, including clinical design and time planning

The FDA must submit the above materials before September 16
.

01 The scope of approved indications far exceeds clinical trials

In fact, doubts about the scope of Aduhelm's indications have never stopped
.

On June 8, the FDA approved the marketing application of Aduhelm, which can be "used for all patients with Alzheimer's disease", and subsequently modified to be used for mild patients
.

On September 1, an analyst from RBC Capital Markets pointed out that during the two clinical trials of Emerge and Engage conducted by Bojian (the subsequent approvals were mainly based on these two clinical trials), a geriatric clinic in Milan, Italy Of the 911 patients, only 6 patients (less than 1%) met the subject requirements
.

The analyst also pointed out that although the FDA has narrowed the scope of indications for Aduhelm, this scope is still widely labelled with subjects in the two clinical trials of Emerge and Engage.
If the new scope is applied to this outpatient clinic in Milan, 911 patients Approximately 34% of patients, or 311 patients, will meet Aduhelm's approved indication range, which is almost 52 times the number of clinical subjects before
.

"Although the benefits observed in clinical trials can be effectively translated into the real world is always a question, this comparison highlights the potentially huge limitations of the EMERGE and ENGAGE trials,
" the analyst said
.
Once Aduhelm is used in a wider range of patients, the side effects that will occur are unknown

According to the news released by Bojian during the International Alzheimer's Conference in July, Aduhelm is conducting a fourth phase observational study on drug safety and patient impact, with more than 6000 patients being tested
.

One of the researchers said in an interview with the media that the study of Aduhelm's impact on different patients included 500 African-Americans and 500 Hispanics.
Among them, patients suffered from diabetes, high blood pressure, and cancer.

In addition, the aforementioned analysts pointed out that Aduhelm's pricing and scope of indications will affect its potential breadth of reimbursement, and Bojian is still waiting for the underwriting decision of Centers for Medicare & Medicaid Services (CMS)
.
The Department of Veterans Affairs has decided not to cover the drug because there is no evidence that the FDA's approval of Aduhelm for all Alzheimer's patients is reasonable

02 Pricing in doubt

Soon after Aduhelm was approved, Bojian announced its pricing.
The price of Aduhelm in the US market is US$4,312 per injection (based on an average weight of 74kg).
The annual treatment cost is as high as US$56,000, which is much higher than the forecast of analysts and advisory groups.

.

Some analysts said that according to Bojian’s pricing, when 500,000 patients use the drug through the Medicare medical insurance provided by the US federal government for people over 65 years old, Aduhelm may spend about 29 billion U.
S.
dollars on Medicare medical insurance every year.
If the number of patients reaches the highest value of Bojian’s expected target number, which is 2 million, Medicare insurance may cost more than 100 billion US dollars, which is almost 5 times the previous budget of the US government for this
.
The "New York Times" also pointed out that this cost has exceeded the US government's budget for the entire NASA (NASA)

Therefore, Carolyn Maloney, Democrat of the US House of Representatives and Chairman of the Oversight Reform Committee, and Frank Pallone, Democrat of New Jersey, and Chairman of the House Energy and Commerce Committee, decided to lead the investigation to investigate the reasons behind the accelerated approval of Aduhelm by the FDA and the broad labeling of the drug
.

It is worth noting that this survey also requires Bojian and the FDA to provide detailed information on the time, location, attendees, and meeting minutes of the informal meetings between Bojian and FDA executives after 2019
.

At the same time, Bojian also needs to provide a detailed breakdown of the costs incurred in its development of Aduhelm, as well as all documents related to pricing, raw tea costs, commercialization or marketing strategies
.

Despite the various investigations and the slow review of CMS, Biogen is still actively promoting the popularization of Aduhelm in the hospital.
Jeffrey Gelblum, a neurologist at the Aventura Center in Florida, said that in order to speed up treatment, Biogen has started the Florida First Choice Neurology project.
Aduhelm is provided free of charge in China
.
Bojian also said that the company has formulated a series of plans to support patients in obtaining treatment, but did not disclose more details