Accord BioPharma announced today, in partnership with Foresee Pharmaceuticals Co., Ltd., the U.S. launch of CAMCEVI™ (leuprolide) 42mg injection emulsion for the treatment of advanced prostate cancer in adults. The U.S. Food and Drug Administration approved the New Drug Application (NDA) of CAMCEVI from Foresee Pharmaceuticals on May 25, 2021. CAMCEVI™ 42 mg injection is exclusively licensed to Accord BioPharma in the U.S. for commercialization.
“The U.S. launch of CAMCEVI validates the importance of Foresee’s pioneering Stabilized Injectable Formulation (SIF) technology and is a monumental step toward fulfilling our mission of improving on a standard of care,” said Dr. Ben Chien, founder and Chairman of Foresee. “We know that Accord BioPharma shares in that important goal.”
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 48.1 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.1
“Accord Healthcare has been providing quality pharmaceutical products in the U.S. since the early 2000s. Through this partnership with Foresee on the launch of CAMCEVI, we are excited to formally launch Accord BioPharma with razor sharp focus on specialty pharmaceuticals, which will go beyond biology to bring more access to high-quality medicines to patients across the U.S.,” said Binish Chudgar, Chairman, Accord Healthcare and Accord BioPharma.
“Foresee’s technology allows us to offer a therapy for advanced prostate cancer that is both effective and convenient for practitioners, with the pre-filled syringe providing simplified preparation that leads to an improved treatment experience for healthcare professionals,” said Chrys Kokino, President of U.S. BioPharma at Accord BioPharma. “CAMCEVI marks an important example of our philosophy – going beyond biology – in action.”
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.