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Today(June 12), the latest information disclosed on the official website of China's National Medical Products Administration (NMPA) shows that a new drug of Class 5.1 applied for by Eli Lilly and CompanyNasal Powder Inhaler for HyperglycemiaThe marketing application has been approved.According to an earlier press release from Eli Lilly and Company, the drug is aNasal Powder Spray of Glucagon Administered by Intranasal Delivery(Product name: Baqsimi), the indication approved this time isFor the treatment of severe hypoglycemia in diabetes patients aged 4 years and above. Notably, in April 2023,Eli Lilly and Company hasAnnounced the sale of global rights for Baqsimi to Amphastar, in a deal worth up to$1.075 billion.
Screenshot source:NMPA Official Website
Public data shows that patients with diabetes may experience severe hypoglycemia as a result of insulin treatment. Severe hypoglycemic events are often overlooked by the public, but if not treated promptly, they can lead to very serious consequences such as loss of consciousness, seizures, coma, or even death, as well as long-term effects like irreversible brain damage and increased risks of macrovascular and microvascular events. Research indicates,Irreversible brain damage occurs after 30 minutes of persistent hypoglycemia.。People with severe hypoglycemic episodes often require treatment with glucagon injections, which are a type of injectable solution.Complex operation is required during use, including reconstitution, air removal, and professional injection techniques, which cannot meet the on-site emergency needs for severe hypoglycemia.
Baqsimi is a nasally administered glucagon powder spray.According to the public information released earlier by Eli Lilly and Company,It is administered using a single-dose applicator.By stimulating the liver to release stored glucose into the bloodstream, thereby increasing the patient's blood sugar levels.。In severe lowIn the emergency treatment of hypoglycemia, the drug is passively absorbed through the patient's nasal mucosa, without requiring the patient to inhale.At the same time,The drug can be administered by a non-professional within 30 seconds, with a success rate of over 90%.
Research shows,Use Glucagon Injection or BaqsimiBoth can rapidly and effectively increase blood glucose levels in patients with severe hypoglycemia, but compared with glucagon injection, the useBaqsimiPatientsSecondary Hyperglycemia(Refers to blood glucose exceeding 10 mmol/L one hour after administration)The risk is relatively lower.AndBaqsimiSmall volume, can be stored at room temperature, portable, with a fixed single-dose of 3 milligrams (no suspension required).
In July 2019, the FDA announced the approval of Baqsimi powder.For the treatment of severe hypoglycemia in diabetes patients aged 4 years and above. According toFDA's earlier press release, this is also itsFirst ApprovalNon-injectable glucagon therapy for severe hypoglycemia emergency treatment.Previously, the NMPA had approved the drug for review based on global data and real-world usage studies, exempting it from clinical trials in China.In April 2023, Eli Lilly and Company announced that it would sell the global rights of Baqsimi to Amphastar, which will...Eli Lilly pays $500 million in cash and an additional $125 million in cash upon the first anniversary of the completion of the transaction.Eli Lilly is also eligible for sales-based milestone payments totaling up to $450 million.According to an earlier press release from Eli LillyThe registration application for Baqsimi for the treatment of severe hypoglycemia is primarily based on 11 global studies involving over 500 subjects, including healthy individuals, adults and children with type 1 and type 2 diabetes. The comparator drug in all studies was glucagon injection. Both global adult and pediatric studies have confirmed...Baqsimi has similar efficacy and safety to glucagon injection, with both having a 100% treatment success rate (defined as the patient regaining consciousness and returning to normal status within 30 minutes after a single dose).。In terms of safety, the common adverse reactions are mainly nausea, vomiting, and headache, which are typical of glucagon-class drugs already on the market.Adverse reactions related to the route of administration were all mild to moderate and transient.Real-world usage studies have further confirmed that Baqsimi is effective, safe, and convenient to use.94% of administrators found it very convenient to use., without serious adverse reactions.Global data shows that, regardless of 1Type 1 or Type 2 diabetes patients experience approximately 87% of severe hypoglycemic events at home.Statistics indicate that in China, the average time for patients experiencing severe hypoglycemia to receive aid is 2.6 hours. At the time of receiving aid, the patients' blood glucose levels are critically low, averaging only 1.6 mmol/L, and the success rate of out-of-hospital emergency treatment is merely 29.7%.This shows that the existing treatment methods have not fully met the needs of on-site first aid for severe hypoglycemia.We hope that this nasal glucagon powder spray will soon be available to patients, allowing more patients to receive timely and convenient on-site rescue during severe hypoglycemic events through a simple nasal spray administration method.[1] Drug Approval Certificate Delivery Information on June 12, 2024. Retrieved June 12, 2024, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240612124002121.html [2] Eli Lilly's Baqsimi® (Glucagon Nasal Powder) Submits Registration Application in China. Retrieved Aug 2, 2022, from https://mp.weixin.qq.com/s/_OytfC_TxMN1wATY4roJrg[3]FDA approves first treatment for severe hypoglycemia that can be administered without an injection. Retrieved July 24, 2019, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-severe-hypoglycemia-can-be-administered-without-injection?utm_campaign=07242019_PR_FDA%20approves%20nasal%20powder%20glucagon%20hypoglycemia%20treatment&utm_medium=email&utm_source=Eloqua[4]Lilly to Divest BAQSIMI to Amphastar. Retrieved Apr 24, 2023, from https://investor.lilly.com/news-releases/news-release-details/lilly-divest-baqsimi-amphastarThis article was compiled and edited by the content team of WuXi AppTec based on publicly available information. Feel free to share it on your personal social media feed.For reprint authorization, please leave a message to contact us on the "Medview" WeChat Official Account. For other cooperation needs, please contact wuxi_media@wuxiapptec.com.
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