Foresee Pharmaceuticals (6576.TWO), (“Foresee”) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI ETM (leuprolide mesylate 21 mg, ready-to-use long-acting injectable (LAI) formulation administered every 3 months), as a treatment for advanced prostate cancer.
“The approval of CAMCEVI ETM (21 mg) is a significant step toward our mission in improving the standard of care and the lives of patients,” said Dr. Ben Chien, founder, Chairman, and CEO of Foresee. “It is also a key step in our efforts to build Foresee as a profitable and growing business. We want to thank the team and all stakeholders for their tireless work, which has made this approval possible.
The FDA approval was based on the successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with CAMCEVI ETM was demonstrated to be effective, safe, and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint.
As it was the case for CAMCEVI 42 mg, we anticipate the commercial launch to take place after obtaining a J-code. The commercial market access strategy established by our partner will seek to find a balance between near term uptake and the optimization of mid/long term growth.
CAMCEVI ETM is exclusively licensed to Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd. for commercialization in the U.S.
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