Ipsen seeks marketing authorization from FDA for Somatuline Depot 120mg injection

Ipsen Biopharmaceuticals, Inc., the U.S. affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) today announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Somatuline® Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). 

In the European Union, Ipsen has submitted national marketing authorization variations for Somatuline® Autogel® 120mg injection to the drug regulatory authorities in 25 countries.

Following EU and U.S. submissions, Ipsen intends to implement worldwide submission roll-out.

Regulatory submission is supported by the results of the CLARINET® Phase III study, which demonstrated the antiproliferative effect of Somatuline® in the treatment of patients with GEP-NETs. The data from CLARINET® showed that investigational treatment with Somatuline® substantially prolonged time to disease progression or death versus placebo (hazard ratio 0.47, p=0.0002). Safety data generated from the CLARINET® study were consistent with the known safety profile of Somatuline®.

Marc de Garidel, Chairman and Chief Executive Officer of Ipsen stated:

There are significant unmet medical needs among GEP-NET patients and Ipsen is committed to help address them. The submission of supplemental marketing authorization applications in the U.S. and variations in Europe for Somatuline® is evidence of our commitment to targeted oncology, and we are pleased to be able to submit them in our planned timeframe.

The data from CLARINET® is purely investigational, as Somatuline® is not authorized for the indication of antiproliferative treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in any market. In many countries where it is marketed as Somatuline® Autogel®, Somatuline® is approved for treatment of acromegaly and for the symptoms associated with neuroendocrine tumors, which can include the treatment of GEP-NET patients experiencing symptoms from carcinoid syndrome, and Somatuline® is approved in many countries for the treatment of acromegaly. Somatuline® Depot is approved in the U.S. for the treatment of acromegaly but not for the treatment of GEP-NETs or the symptoms thereof.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
You might also like... ×
Cysteamine inhibits SARS-CoV-2 variants of concern in vitro