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Extended dosing interval approved for lanreotide injection
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The FDA has approved a prior approval supplement application for the extended dosing interval of lanreotide injection for the treatment of patients with acromegaly, according to Ipsen.
The approval will allow Ipsen to revise the US package insert for patients with acromegaly who are treated with lanreotide injection 60 mg or 90 mg (Somatuline Depot) to be treated on an extended dosing interval of 120 mg every 6 or 8 weeks. According to the label, growth hormone and insulin-like growth factor I levels should be obtained 6 weeks after this change to evaluate patient response.
The extended dose interval may provide patients with acromegaly the possibility to reduce the number of injections per year.
According to Ipsen, lanreotide was marketed in more than 54 countries at the end of 2010. The extended dosing interval has already been approved in all European countries where the drug (Somatuline Autogel) is registered.
Lanreotide is a somatostatin analog that inhibits the secretion of several endocrine, autocrine and paracrine functions. It is effective in inhibiting the secretion of growth hormones and certain hormones secreted by the digestive system.
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