FDA OKs New Pre-Filled Syringe for Lanreotide

Officials with the FDA today approved a new pre-filled syringe for lanreotide (Somatuline Depot, Ipsen Biopharmaceuticals), according to a press release.

The syringe’s new design is intended to enhance the injection experience. It includes updated features, such as larger flanges, to make it easier for health care providers to administer the injection. Lanreotide is for deep subcutaneous injection and is intended for administration by a health care professional.

Lanreotide is a somatostatin analog indicated for:

• The treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
• The treatment of adult patients with carcinoid syndrome to reduce frequency of short-acting somatostatin analog rescue therapy.
• The long-term treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce growth hormone and insulin growth factor-1 levels to normal.

NETs are a group of uncommon tumors that can be found in the gastrointestinal tract, the pancreas, and the lungs. Proper diagnosis can take more than 5 years since symptoms are often not distinct and difficult to identify. Although NETs affect a small percentage of the population, they are currently the fastest growing class of cancers worldwide, according to Ipsen.

Acromegaly is a hormonal or endocrine disorder with slowly developing, but eventually distinct, clinical symptoms caused by excessive growth hormone in the body. Approximately 3500 new cases of acromegaly are diagnosed each year.

The approval of the new pre-filled syringe is based on 5 separate but complementary studies. Based on the study results, the delivery system was redesigned to make it easier to grip the syringe and administer the injection. Other new features include a needle shield removal system, more stable plunger, and thermoform tray that has recessed areas to help prevent accidental plunger depression.

The new syringe design also contains the built-in safety system from the previous pre-filled syringe.

“We consistently look for opportunities to respond to the needs of the communities we serve, and this approval would not have been possible without the direct involvement of nurses and the patients with GEP-NETs and acromegaly whom they treat,” Bradley Bailey, SVP and franchise head oncology/endocrinology business unit at Ipsen, said in a statement. “We listened and collaborated to enhance the existing pre-filled syringe, making it sturdier for health care providers when administering treatment, with the intention of improving the injection process. We look forward to bringing innovation to health care providers for their patients soon.”

According to Ipsen, health care providers can expect to receive the new syringe during Q3 2019.

Reference

Ipsen Announces US FDA Approval for Newly Designed Pre-filled Syringe for Somatuline Depot (lanreotide) [news release]. Ipsen Biopharmaceuticals. https://www.ipsen.com/websites/Ipsen_Online/wp-content/uploads/sites/9/2019/06/24200707/Ipsen_SD_NDS_Approval_Press_Release_6.24.19.pdf. Accessed June 24, 2019.