Ipsen Submits New Indication Application in China for Lanreotide Autogel® for Gastroenteropancreatic Neuroendocrine Tumors

On July 6, the CDE website showed that Ipsen's lanreotide acetate sustained-release injection (Somatuline® Autogel®) applied for a new indication. Based on the public clinical trial progress, it is speculated that the indication applied for this time is gastroenteropancreatic neuroendocrine tumors.

Lanreotide is a somatostatin analog. In 1995, Ipsen launched the polymer microsphere-based long-acting lanreotide injection (Somatuline® PR) in the French market for the treatment of acromegaly. In 2001 and 2007, the hydrogel formulation of the long-acting lanreotide injection, Somatuline® Autogel® (marketed as Somatuline® Depot in the United States), developed by Ipsen, was successively approved for marketing in the UK and the US, and entered the Chinese market in 2021.

In April 2021, Ipsen initiated a Phase III clinical trial in China for Somatuline® Autogel® (120mg, once every 28 days) to treat unresectable locally advanced or metastatic Grade 1 or 2 gastroenteropancreatic neuroendocrine tumors. The study was completed this past March, but the results have not yet been disclosed.

Currently, Somatuline® Autogel® has been approved for three indications worldwide: acromegaly, gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. In 2022, the annual sales of lanreotide reached 1.218 billion euros (approximately 1.282 billion US dollars).

Gastroenteropancreatic Neuroendocrine Neoplasms (GEP-NENs) are highly heterogeneous tumors that primarily occur in the digestive tract or pancreas, capable of producing amine substances and peptide hormones such as glucagon, insulin, gastrin, or adrenocorticotropic hormone. Statistical data shows that the incidence rate of GEP-NENs in the United States was 0.4 per 100,000 in 2012, while in Japan, it was 3.532 per 100,000 in 2016.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; if you need to reprint, please leave a message to the WeChat Official Account or send a message, and include the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content.医药魔方 (MedCube) assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Highlights

Online Live Streaming & Offline Salon

↑ Click to scan the QR code and register for the live broadcast ↑