Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the Food and Drug Administration (FDA) has approved Ipsen's Prior Approval Supplement application for the Extended Dosing Interval of Somatuline® Depot for patients suffering from acromegaly.
The approval revises the US Package Insert to allow acromegalic patient to be treated on an extended dosing interval for up to 8 weeks, through the addition of the following sentence in the labelling: "Patients who are controlled on Somatuline® Depot 60 mg or 90 mg may be considered for an extended dosing interval of Somatuline® Depot 120 mg every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response". The extended dosing interval has already been approved in all European countries where Somatuline® Autogel is registered.
The Extended Dose Interval of Somatuline® Depot 120mg of 6 to 8 weeks will provide patients with acromegaly who are currently controlled on Somatuline® Depot 60mg or 90mg every 4 weeks, a possibility to reduce the number of injections per year.
Stéphane Thiroloix, Executive Vice-President, Corporate Development at Ipsen, said: "This new approval confirms Ipsen's positioning as a patient-centric organization and reaffirms the Group's commitment to innovation for patient care. Ipsen is proud to provide physicians and acromegaly patients with an effective and convenient treatment option specifically developed to meet their medical needs. The Group will aggressively pursue its life cycle management strategy to maximize the potential of Somatuline® Depot and to reinforce its status of key growth driver in the coming years".
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