Ipsen today simultaneously announced the EU launch of a new pre-filled syringe for Somatuline® Autogel® (lanreotide) for patients with neuroendocrine tumors (NETs), acromegaly or symptoms associated with carcinoid syndrome, and released findings from the human factor studies that underpinned its development as a poster presentation (Abstract #H14) at ENETS 2019.1,2 As of April 2019, patients in Ireland will be the first to benefit from the new ready-to-use, pre-filled syringe. Ipsen has confirmed they are committed to making this new pre-filled syringe available to patients and healthcare professionals throughout Europe, the U.S., Canada, Australia and New Zealand during 2019 following necessary regulatory approvals.
The new pre-filled syringe for Somatuline® Autogel® was the result of several studies, involving patients, their caregivers, nurses and other healthcare professionals, to inform and test enhancements to the existing pre-filled syringe.1 Notable new features are modified ergonomics and handling, a needle shield removal system, an injection process with plunger support and heightened ease of use.1 The automatic, built-in safety system, which helps to prevent needle stick injury by locking in place following the administration, has not been changed.
“Today’s announcement around the EU launch of a new pre-filled syringe for Somatuline® Autogel® is not only an important new option for patients living with acromegaly and NETs but represents a significant milestone in our commitment to patient-centric innovation,” said Bartek Bednarz, Senior Vice President, Global Oncology Franchise at Ipsen. “We are also proud to be sharing as a poster presentation at ENETS 2019 the results of several studies, where we tested, evolved and validated changes for every stage of the Somatuline® Autogel® injection experience”, added Sotirios Stergiopoulos, Chief Medical Officer at Ipsen.
“NETs and acromegaly can be associated with a number of uncomfortable and unpleasant symptoms, so any innovation that eases the physical challenges of treatment for the patient and their healthcare team is a step forward,” said Daphne T Adelman, Clinical Nurse Specialist from Northwestern University in Chicago, U.S. and one of the authors of the study.
Somatuline® Autogel® is made of the active substance lanreotide, which is a somatostatin analogue that inhibits the secretion of growth hormone and certain hormones secreted by the digestive system. The main ndications of Somatuline® and Somatuline® Autogel® are:2
• The treatment of individuals with acromegaly when the circulating levels of Growth Hormone (GH) and/or Insulinlike Growth Factor-1 (IGF-1) remain abnormal after surgery and/or radiotherapy, or in patients who otherwise require medical treatment.
• The treatment of grade 1 and a subset of grade 2 (Ki-67 index up to 10%) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease.
• The treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumors.
Important Safety Information
• The detailed recommendations for the use of Somatuline® Autogel® are described in the Summary of Product.
1. Data on file. ENETS 2019
2. Somatuline® Autogel® SmPC. November 2018
Ipsen (ipsen.com) is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. Its commitment to Oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.2billion in 2018, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen's R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,700 employees worldwide.
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