Ipsen abandons EU NutropinAq application

French drugmaker Ipsen has withdrawn an application relating to its recombinant human growth hormone product NutropinAq (somatropin) from European Medicines Agency (EMEA) review. Ipsen had been seeking to extend the product's indication to include the treatment of severe idiopathic short stature but, following the Committee for Medicinal Products for Human Use's (CHMP) issuance of a negative approval opinion in September last year, has decided to discontinue its efforts in this direction.

The CHMP which, in response to an Ipsen request, was in the process of re-examining its decision at the time of withdrawal, originally concluded that data provided by the firm had not been sufficient to support the drug's use in ISS. The committee said that it would publish full details of its decision, as well as Ipsen's withdrawal letter, on its web site in due course.

At present, NutropinAq holds European approval for the treatment of growth failure caused by disorders including: inadequate endogenous growth hormone secretion; Turner syndrome; and chronic renal insufficiency. In the USA, where the drug is marketed in collaboration with biotechnology giant Genentech, the Food and Drug Administration approved its use in ISS in 2005 (Marketletters passim).