Ipsen Applies For Multiple Drug Marketing Authorizations

Ispen has announced that it has filed for multiple drug marketing authorizations in both the U.S. and the EU. Ispen has filed a Supplemental New Drug Application with the FDA for its Somatuline Depot 120 mg injection.

In the EU, Ispen filed national marketing authorization variations for the drug. The application was filed with the 25 countries that comprise the EU. Ispen has stated that, after the filings in the EU and the U.S., the company plans to begin a worldwide submission process.

The drug is used in the treatment of gastroenteropancreatic neuroendocrine tumors, or GEP-NETs. GEP-NETs are fairly rare but are very serious forms of cancer. The cancer is typically associated with the gastrointestinal tract and the pancreas. The cancer can be very difficult to detect, which oftentimes leads to a late diagnosis. Although the cancer is considered rare, its incidence has been increasing recently. In the past 30 years, there has been a 4 to 6 fold increase in the number of cases.

The CLARINET Phase 3 study conducted by Ispen found that the company’s GEP-NETs treatment significantly prolonged time to disease progression or death when compared with the placebo. Studies of the drug also showed that it was well tolerated and generally safe for patients.

Marc de Garidel, the chairman and CEO of Ispen, released a statement on the filings. “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,” he said.