TERCICA SUBMITS NDA FOR ACROMEGALY TREATMENT
Tercica has reported that earlier this week its partner Ipsen submitted a new drug application (NDA) to the FDA for Somatuline Autogel (lanreotide acetate) injection, 60, 90 and 120 mg, to treat patients with acromegaly. Tercica licensed from Ipsen the rights to develop and market the drug in the United States and Canada. The FDA will determine within 60 days whether the submission will be accepted for filing.
Somatuline and Somatuline Autogel have received marketing authorizations in more than 50 countries for the treatment of acromegaly and neuroendocrine tumors. The product is supplied in prefilled syringes to be injected subcutaneously for easier administration than other long-acting somatostatin analogues.
In July Health Canada approved Somatuline Autogel for the long-term treatment of patients with acromegaly due to pituitary tumors who have had inadequate response to or cannot be treated with surgery and/or radiotherapy and for the relief of symptoms associated with acromegaly. The company expects to introduce the drug in Canada in early 2007.
Somatuline Autogel is an injectable sustained-release formulation containing lanreotide, a somatostatin analogue. Somatuline was initially developed in Europe for the treatment of acromegaly (a disorder caused by the over-production of growth hormone secondary to a benign tumor of the anterior pituitary gland) and, in most European countries, is also approved for the treatment of symptoms associated with neuroendocrine tumors. The Autogel formulation requires no excipient other than water and releases lanreotide over a period of at least 28 days and up to 56 days. In acromegaly, Somatuline is used primarily when circulating levels of growth hormone remain high despite surgery or radiotherapy, and through its inhibitory effects Somatuline lowers growth hormone and IGF-1 levels, controlling disease progression and relieving the symptoms associated with active disease.