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Ipsen Ltd Withdraws Its Application For An Extension Of Indication For NutropinAq, Europe
The European Medicines Agency (EMEA) has been formally notified by Ipsen
Ltd of its decision to withdraw its application for an extension of
indication for the centrally authorised medicine NutropinAq
(somatropin).
NutropinAq was expected to be used for the treatment of children with
severe idiopathic short stature (short height not explained by growth
hormone deficiency or other medical conditions) with a predicted adult
height of at least 1 standard deviation score below the target height.
NutropinAq was first authorised in the European Union on 16 February
2001. It is currently indicated for use in the long-term treatment of
children with growth failure due to inadequate endogenous growth hormone
secretion, long-term treatment of growth failure associated with Turner
syndrome, treatment of prepubertal children with growth failure
associated with chronic renal insufficiency up to the time of renal
transplantation, and replacement of endogenous growth hormone in adults
with growth hormone deficiency of either childhood or adult-onset
aetiology.
The application for the extension of indication for NutropinAq was
submitted to the EMEA on 18 April 2006. The Agency's Committee for
Medicinal Products for Human Use (CHMP) had given a negative opinion
recommending the refusal of a marketing authorisation in 27 September
2007. The company had requested a re-examination of the negative
opinion, which had not yet finished when the company withdrew.
In its official letter, the company stated that the withdrawal of the
application was based on the CHMP's opinion that the data provided did
not allow the Committee to recommend authorisation of the extension of
the marketing authorisation in the proposed indication.
More information about NutropinAq and the state of the scientific
assessment at the time of withdrawal will be made available in a
question-and-answer document. This document, together with the
withdrawal letter from the company, will be published on the EMEA
website in due course.
Notes:
1. Withdrawal of an application does not prejudice the possibility
of a company making a new application at a later stage.
2. More information about NutropinAq is available in the European
Public Assessment Report (EPAR): see here.
European Medicines Agency
Ipsen Ltd cu retragerea cererii pentru o prelungire a indicaþie pentru NutropinAq, Europa - Ipsen Ltd Withdraws Its Application For An Extension Of Indication For NutropinAq, Europe - articole medicale engleza - startsanatate