French drugmaker Ipsen and its US partner Tercica have been cheered by the news that the European Union's advisory panel has recommended approval of Increlex, the companies’ treatment for growth failure in children and adolescents.
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on Increlex (mecasermin) for the long-term treatment of growth failure in children with severe primary insulin-like growth factor-1 deficiency and in children with growth hormone gene deletion who have developed neutralising antibodies to GH. The CHMP's positive opinion was based on clinical data from 76 patients who were treated with Increlex for up to 12.5 years. The primary endpoint in the pivotal clinical study was height velocity, which increased from an average of 2.8cm per year at baseline to an average of 8.0cm per year in the first year of treatment.
Given the recommendation, Ipsen is now expecting to get approval in two to three months and because Increlex has orphan drug designation in the European Union, this will provide ten years of marketing exclusivity for the treatment. Once the green light is confirmed, the French firm will pay Tercica, which has been selling Increlex in the USA since early 2006, a milestone payment of 15 million euros.
Christophe Jean, Ipsen’s chief operating officer, said the addition of Increlex to its existing global endocrinology portfolio, which also includes Somatuline (lanreotide) for acromegaly and the recombinant human growth hormone NutropinAq (controlled-release somatropin) “further reinforces the company's global franchise in this high-growth therapeutic area”.