- Source : Press Release
- Date : 2020-11-10
- Event type : Approved
- Companies : Clinigen Group plc
Clinigen's Totect (Dexrazoxane) Receives FDA Approval for New Indication to Treat Incidence and Severity of Cardiomyopathy Associated with Doxorubicin in Women with Metastatic Breast Cancer
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, announced today that the FDA has granted approval to broaden the indication for Totect® to now include reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Totect® was first approved in September 2007 for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.
Shaun Chilton, Group Chief Executive Officer, Clinigen, said: “This exceptional accomplishment by our Global Regulatory and Medical Affairs teams makes Totect® the first and only FDA approved dexrazoxane product with a dual indication for the treatment of extravasation resulting from intravenous anthracycline chemotherapy as well as cardiomyopathy associated with doxorubicin in appropriately indicated women with metastatic breast cancer. As we continue to expand our global footprint, our commitment and primary focus remains on fulfilling our corporate mission to deliver the Right Medicine to the Right Patient at the Right Time.”
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Clinigen Group plc
Shaun Clinton, Group Chief Executive Officer
Nick Keher, Group Chief Financial Officer
Tel: 44 (0) 1283 495010
Melanie Toyne-Sewell, Phillip Marriage, Nathan Billis
Tel: 44 (0) 20 7457 2020
About Clinigen Group
Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing ethical access to medicines. Its mission is to deliver the right medicine to the right patient at the right time through three areas of global medicine supply; clinical trial, unlicensed and licensed medicines. The Group has sites in North America, Europe, Africa and the Asia Pacific.
Clinigen now has over 1,150 employees across five continents in 14 countries, with supply and distribution hubs and operational centres of excellence in key long-term growth regions. The Group works with 21 of the top 25 pharmaceutical companies; interacting with over 18,000 registered users across over 115 countries, shipping approximately 6.5 million units in the year.
For more information on Clinigen, please visit www.clinigengroup.com