Ipsen has formally notified the European Medicines Agency (EMEA) it has decided to withdraw its application for an extension of indication for NutropinAq (somatropin).
The drug was expected to be used to treat children with severe idiopathic short stature, which is short height not explained by growth hormone deficiency or any other medical conditions.
The treatment was first authorised in the European Union on 16 February 2001, and is currently indicated for use for a host of conditions including the long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion, and the long-term treatment of growth failure associated with Turner syndrome.
The application for the extension was submitted to the EMEA on 18 April 2006, but on 27 September 2007, the Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended that a marketing authorisation should be refused.
Ipsen had asked the CHMP to reconsider its position, which it was in the process of doing when the company decided to withdraw.
The company stated its decision was based on the CHMP’s opinion that the data provided did not allow it to recommend that the marketing authorisation in the proposed indication should be extended.
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