Ipsen Ltd, the UK subsidiary of the Ipsen Group, has expanded its short-stature treatment portfolio with the launch this week of Increlex® (mecasermin), a recombinant DNA-derived human insulin-like growth factor-1 (IGF-1). Increlex® was launched at the 35th Meeting of the British Society of Paediatric Endocrinology and Diabetes in Cambridge.
Increlex® is the first and only product licensed in Europe for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (IGFD).
Severe Primary IGFD is a complex condition where children’s IGF-1 levels are low, despite the presence of normal or elevated Growth Hormone (GH) levels. Without adequate IGF-1 these children cannot achieve normal height.
Severe Primary IGFD is defined in the licence approval by several key factors:
· Height standard deviation scores < -3.0 and
· Basal IGF-1 levels below the 2.5th percentile for age and gender and
· GH sufficiency
· Exclusion of the secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacological doses of anti-inflammatory steroids
An IGF-1 generation test can be used to confirm diagnosis.
Ipsen’s short stature treatment portfolio also includes NutropinAq®, a liquid formulation of somatropin (recombinant DNA origin, Escherichia coli) for the treatment of growth hormone deficiency in adults and children, Turner syndrome and chronic renal insufficiency.
Increlex® has been marketed in the USA by Tercica since early 2006. Exclusive rights to develop and commercialise Increlex were licensed to Ipsen in October 2006 for all regions of the world except the USA, Japan, Canada, Taiwan and certain countries of the Middle East and North Africa.
Increlex® should be used by clinicians experienced in the diagnosis of growth disorder and each dose should be tailored to the patient. The product is available in a 10mg/mL solution and costs £384 per 40mg (4mL) vial.