Ipsen Announces U.S. FDA Approval of Redesigned Pre-Filled Syringe for Somatuline® Depot (Lanreotide)

June 26, 2019 News /BioValleyBIOON/ -- Ipsen's subsidiary, Ipsen Biopharmaceuticals, recently announced that the U.S. Food and Drug Administration (FDA) has approved a new pre-filled syringe for Somatuline® Depot (lanreotide injection), featuring updated functionalities such as larger flanges to facilitate administration by healthcare providers.ipsThe company has planned to launch this new pre-filled syringe on the market in the third quarter of this year. The drug will be administered via deep subcutaneous injection by healthcare professionals.

This new pre-filled syringe has the same indications as the previous pre-filled syringe. The drug, a somatostatin analog, is indicated for: (1) the long-term treatment of patients with acromegaly who have had an insufficient response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy are not appropriate treatment options, with the aim of reducing growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels to normal ranges; (2) the treatment of patients with unresectable, well-differentiated or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumorsTumor(GEP-NET) adult patients to improve progression-free survival; (3) treating adult patients with carcinoid syndrome can reduce the frequency of rescue therapy with short-acting somatostatin analogs.

Ipsen collaborated with patients and their caregivers, nurses, and other healthcare professionals to conduct five independent yet complementary studies aimed at better understanding the current use of the existing Somatoline® Depot pre-filled syringe and evaluating methods to improve its functionality. This collaboration resulted in a redesigned delivery system intended to facilitate easier gripping of the syringe and administration of the injection.

Daphne Adelman, a Clinical Nurse Specialist at Northwestern University in the United States and one of the collaborators on the aforementioned study, stated, “GEP-NETs and acromegaly may be associated with certain uncomfortable and distressing symptoms, and innovations aimed at improving the injection process represent a significant step forward in the clinical management of these patients.”(Bio Valley Bioon.com)

Original Source:Ipsen Announces U.S. FDA Approval for Newly Designed Pre-Filled Syringe for Somatuline? Depot (lanreotide)