Recently, media reports have reported that a life-saving drug for treating ALS, Liraglutide tablets (trade name “Lirutai”), have experienced supply disruptions in several large tertiary hospitals in Shanghai. It is understood that the drug is produced by the French pharmaceutical company Sanofi.
On the evening of April 28th, Sanofi China responded to a reporter from First Financial News, “We have made every effort to follow up and resolve the recent feedback from patients and the media regarding the supply situation of ‘Li Ru Tai’ in some hospitals.”
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Changes in overseas production locations of manufacturers require re filing
Sanofi stated that it is coordinating with all parties to strengthen the supply guarantee of the product. “In addition to the main supply hospitals in this city, we will further provide medical information for patients in urgent need of medication based on product inventory in retail channels, to ensure that patients can use medication and solve urgent needs. At the same time, we are actively communicating and cooperating with relevant departments such as pharmacy to accelerate the resolution of possible drug supply problems in some hospitals.” The company told reporters from First Financial News.
According to sources familiar with the situation, some top tier hospitals in Shanghai have been out of stock for at least a month. In a situation statement sent by Sanofi Beijing to medical institutions on March 20th, obtained by the reporter, it was stated: “The name and address of the overseas production enterprise of Liraglutide tablets (LiRuTai) have undergone administrative changes. Due to the recent docking with the national subsystem platform and platform upgrade by the Shanghai Pharmaceutical Institute, the production enterprise information is still under review and has not been updated yet. Our company has followed up in a timely manner and will inform your hospital of the updates as soon as possible.”
The company also stated, “Sanofi guarantees that the current supply and circulation of ‘Li Ru Tai’ are produced and imported into China within the validity period of the approval documents, meeting the requirements of the import drug registration certificate.”
It is worth noting that the change of overseas production address of manufacturers requires re filing on one hand, and on the other hand, in December last year, Sanofi China signed a strategic cooperation agreement with Shanghai Pharmaceutical Group Co., Ltd. Sanofi China told reporters from First Financial that the sales of “Li Ru Tai” have already been undertaken by Shanghai Pharmaceutical Group Co., Ltd., but the process of importing biological preparations is very complex, and this supply change is not due to Shanghai Pharmaceutical Group Co., Ltd.
A neurologist from a top tier hospital in Shanghai told a reporter from First Financial that Sanofi’s “Li Ru Tai” is indeed out of stock recently, and the hospital is actively communicating with the manufacturer. But he pointed out that in the situation where this drug is out of stock, patients are not “without drugs”. Firstly, there are domestically produced generic drugs of liraglutide that can be replaced, although these drugs still lack validation data for large-scale patients, only consistency evaluation data; Another option is to use other therapeutic drugs, such as Edaravone.
The above doctors stated that for patients who have been taking Sanofiruzole for a long time and have good therapeutic effects, changing dressing can indeed bring a lot of inconvenience. Therefore, relevant parties should also start from the patient’s perspective and solve the supply problem as soon as possible.
Is there an alternative option for “life-saving medicine”?
ALS, also known as amyotrophic lateral sclerosis, is a desperate and deadly motor neuron disease. The upper motor neurons in the patient’s brain and the lower motor neurons in the spinal cord will gradually die, and the central nervous system will be unable to send out motor commands, resulting in the loss of control over the limbs in the brain.
From the perspective of patients with ALS, there are currently not many available medications to choose from. So far, there are two main drugs used in clinical practice that can intervene in the progression of diseases. Liluzole is a relatively old drug that was approved by the US FDA in 1996; The newer one is the edaravone approved by the US FDA in 2017 for Japanese company Mitsubishi Tanabe.
There are currently 7 domestically produced liraglutide products on the market in China, from manufacturers such as Lunanbeite Pharmaceutical, Jiangsu Enhua Pharmaceutical, and Wante Pharmaceutical (Hainan).
However, the efficacy of this drug is also controversial. A well-known expert in the field of neurology told a reporter from First Financial News, “The efficacy of Sanofi is not ideal either. Clinical data in Europe shows that compared to placebo, it can only prolong patients’ survival by 3 months.”
The survival period of patients with ALS is generally 3-5 years. Even if there are no other better drugs available, extending the survival period by 3 months is still valuable. Therefore, liraglutide is still the most recommended drug for treating ALS in clinical practice, and it is also the current medical insurance medication for ALS indications.
A neurologist told First Financial reporters that if taken at an early stage of the disease, it will still have significant therapeutic effects on prolonging survival. According to his observation, some patients who have been using liraglutide for a long time have also experienced survival of up to 10 years.
At the same time, the development of new drugs is also being promoted. Recently, the world’s first therapeutic drug targeting the SOD1 gene for ALS, Tofersen, has landed at Ruijin Hainan Hospital. The drug has been approved by the US FDA and submitted a marketing application to the National Medical Products Administration of China in 2023.
The incidence rate of frostbite is about two to three percent of 100000 people. Although the size of the patient group is not particularly large compared with other rare diseases, frostbite is called the “flagship disease” of rare diseases and receives great attention. Famous physicist Hawking is a typical representative of patients with ALS. In 2014, the global Internet launched a donation activity of “Ice Bucket Challenge”, which brought the public’s attention to the epidemic to a climax.
There are approximately 100000 patients with ALS in China. Feng Guodong, Deputy Chief Physician of Zhongshan Hospital Affiliated to Fudan University and Member and Secretary of the Collaborating Group on ALS of the Neurology Branch of the Chinese Medical Association, stated that ALS is a highly heterogeneous disease, with significant differences in symptoms among individuals. Moreover, there are still challenges in diagnosis at present.
“The early symptoms of ALS are not typical and are easily misdiagnosed or missed. Even in the middle stage, many symptoms are suspected of ALS,” he told a reporter from First Financial News. “Especially middle-aged and elderly people with other diseases are prone to misdiagnosis.”
Generally speaking, the age range of 40 to 60 years old is a high incidence stage for ALS, but older adults can also develop the disease. “Damage to functions such as breathing, movement, language, and swallowing can all occur in ALS,” Feng Guodong said. “If the rehabilitation and care issues of ALS are solved, many other diseases’ problems will also be easily solved.”