Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd. focused on development of oncology, immunology, and critical care therapies, announced today the U.S. launch of CAMCEVI™ (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults. Accord BioPharma is heading distribution in the U.S. The U.S. Food and Drug Administration approved the New Drug Application (NDA) of CAMCEVI from Foresee Pharmaceuticals on May 25, 2021.
CAMCEVI is the first-ever ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required. In an open-label, single-arm study of 137 adults who received 42mg of CAMCEVI on Day 0 and Week 24, CAMCEVI offered consistent testosterone suppression to castrate levels after the initial injection, from Week 4 to Week 48. CAMCEVI should not be used in patients with hypersensitivity to GnRH or GnRH analogs due to possible anaphylactic reactions.1 The most common adverse reactions (≥10%) occurring during a median follow-up duration of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.
Eligible patients prescribed CAMCEVI will have access to support services, such as commercial copay assistance solutions, patient assistance programs, and a nurse-staffed clinical hotline that provides on-demand answers to questions from patients or their care team. These patient support services are uniquely designed to meet the needs of our patient population, helping remove barriers to therapy and supporting patients throughout their healthcare journey with CAMCEVI. To learn more, visit www.camcevihcp.com.
Additionally, Accord BioPharma offers healthcare professionals access to AccordConnects™, a mobile application designed to help healthcare practices manage in-practice inventory of CAMCEVI. The app enables healthcare practices to scan barcodes to accurately log CAMCEVI physical inventory count, project future product inventory requirements, run inventory stock and utilization reports, and allows for forward and backward traceability to locate product.
“The U.S. launch of CAMCEVI demonstrates our commitment to going beyond the biology of medicine, to see disease from a patient’s perspective and develop high-quality therapies that enhance the overall treatment experience,” said Chrys Kokino, President of U.S. BioPharma at Accord BioPharma.
Important Safety Information: CAMCEVI, like other GnRH agonists, causes a transient increase in serum levels of testosterone during the first week of treatment which can cause transient worsening of symptoms. Patients with metastatic vertebral lesions and/or with urinary tract obstruction should be closely observed during the first few weeks of therapy. Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in association with the use of GnRH agonists. Patients should be monitored for cardiovascular disease and according to current clinical practice. Androgen deprivation therapy may prolong the QT interval. Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI. Monitor serum levels of testosterone following injection of CAMCEVI. Based on findings in animal studies and mechanism of action, CAMCEVI may cause fetal harm when administered to pregnant women. The most common (≥10%) adverse reactions during a median follow-up of 336 days were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremities.