EVERSANA, a US-based company involved in providing commercial services to the global life sciences industry, and Accord BioPharma, the United States specialty division of Intas Pharmaceuticals, Ltd., announced on Wednesday that they have collaborated to support the introduction of CAMCEVI (leuprolide) 42mg injection emulsion to treat advanced prostate cancer in adults.
CAMCEVI's US distribution is headed by Accord BioPharma. Foresee Pharmaceuticals received approval from the United States Food and Drug Administration (FDA) for CAMCEVI's New Drug Application (NDA).
EVERSANA said that CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide for subcutaneous injection that is available in a pre-filled syringe with no mixing needed. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24, the product provided consistent testosterone suppression to castrate levels after the initial injection, from Week 4 to Week 48. The product should not be used in patients with hypersensitivity to GnRH or GnRH analogues due to possible anaphylactic reactions.
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