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December 17, 2021December 17, 2021 – The U.S. FDA has approved Invagen Pharma's lanreotide subcutaneous injection as the first generic version of Ipsen's Somatuline® Depot (lanreotide).
- Invagen's generic is indicated to provide:
- Long-term treatment for patients who have acromegaly (a condition caused by overproduction of growth hormone from the pituitary gland) and have had an inadequate response to or cannot be treated with surgery and/or radiotherapy; and
- Treatment for adults who have unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
- Unlike Somatuline Depot, Invagen's generic is not currently FDA approved to treat adults who have carcinoid syndrome (a group of symptoms caused by a rare form of tumor).
- Both medications are administered by a healthcare provider via deep subcutaneous injection. The recommended dosing is:
- For Acromegaly: 90mg once every four weeks for three months, then adjusted thereafter based on clinical response.
- For GEP-NETs: 120mg once every four weeks.
- Invagen's generic is available at a wholesale acquisition cost (WAC) of $8,892.66 per syringe compared to $9,150 for Somatuline Depot.