French drugmaker Ipsen has announced that the European Commission has granted marketing authorisation for Increlex, a new product to treat a growth disorder in youngsters.
The drug has been given the green light for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency and comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on Increlex (mecasermin) in May. In May last year, Increlex was designated as an orphan drug in the European Union, which means that it will enjoy ten-year marketing exclusivity, and a launch is now planned for October.
“The effect of growth hormone is to a major part mediated by insulin-like growth-factor-1,” noted Michael Ranke at the paediatric endocrinology section at the University of Tuebingen, Germany. He added that if the biochemical steps leading to the formation of IGF-I are interrupted then patients cannot respond to growth hormone therapy and replacement
with IGF-1 “is the pathogenetically appropriate therapy in these instances” and “Increlex thus opens a new field for the treatment of previously untreatable children with severely short stature”.
Ipsen got hold of the European rights to Increlex from Tercica, which has been selling the treatment in the USA since early 2006, and the approval triggers a 15 million euro milestone payment by the French firm to its US partner. Christophe Jean, Ipsen’s chief operating officer, added Increlex “fits perfectly in our existing global endocrinology franchise, along with Somatuline (lanreotide) and NutropinAq (controlled-release somatropin) to provide…a comprehensive solution for the treatment of patients suffering from growth disorders”.