- The FDA approves Novartis' (NYSE:NVS) Signifor long-acting release (LAR) (pasireotide) for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for who surgery is not an option.
- Acromegaly is an endocrine disorder caused by elevated growth hormone and insulin-like growth factor. It is characterized by increased bone growth including the hands, feet and face. The most frequent cause is a non-cancerous tumor on the pituitary gland.
- Signifor LAR is Orphan Drug designated in the U.S. for the treatment of acromegaly so it has a seven-year period of market exclusivity. It was cleared in Europe last month for this indication.
- The product was originally approved for the treatment of Cushing's disease.
- Related ticker: (OTCPK:IPSEY)
- Previously: Europe clears label expansion for Novartis' Signifor (Nov. 24, 2014)