Amgen Launches Global First-in-Class Osteoporosis Drug Evenity® in Japan for High-Risk Male and Postmenopausal Female Patients

March 6, 2019/BioValleyBIOON/--US biotechnology giant Amgen, its Japanese joint venture with Astellas Pharma, Amgen Astellas BioPharma K.K. (AABP), Astellas, and UCB jointly announced the launch of the new osteoporosis drug Evenity (romosozumab) in Japan. The drug is indicated for postmenopausal women and men at high risk of fracture to reduce the risk of fractures and increase bone mineral density.

Evenity is being co-developed globally by Amgen and UCB, with development in the Japanese market led by AABP. In Japan, Evenity was approved this January, marking the drug’s first regulatory approval worldwide. Currently, Evenity is also under review by the U.S. FDA and the European EMA. In the United States,FDAThe Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) convened in mid-January this year.Meeting, and supported the approval of the Biologics License Application (BLA) for Evenity for the treatment of osteoporosis in postmenopausal women at high risk for fracture, with a vote of 18 in favor and 1 against.FDAThe BRUDAC recommendations will be considered in making the final review decision, although they are not binding.

Evenity is a fully human monoclonal antibody that functions by inhibiting the activity of sclerostin. As a bone-forming agent, Evenity exerts a dual effect: it increases bone formation while reducing bone resorption, thereby increasing bone mineral density (BMD) and lowering the risk of fracture. Sclerostin, also known as sclerostin protein, is a secreted glycoprotein encoded by the SOST gene. In vivo studies have demonstrated that sclerostin is specifically expressed in osteocytes and plays a significant role in bone metabolism by acting on osteoblasts. The expression of the SOST gene is influenced by factors such as mechanical stress, hormones, and oxygen concentration. Antagonizing sclerostin can alleviate the symptoms of osteoporosis, providing new insights and approaches for the clinical treatment of osteoporosis and other related conditions.

Amgen has a blockbuster biologic for osteoporosis, Prolia (denosumab), with annual sales of $2 billion, but its patent will expire in a few years. Evenity is positioned as the successor to Prolia, making regulatory approval in major global pharmaceutical markets, particularly in the United States, crucial for this drug.

The Evenity development program includes three pivotal Phase III clinical studies, enrolling more than 11,000 patients. Specifically, the FRAME study enrolled 7,180 postmenopausal women with osteoporosis; the ARCH study enrolled postmenopausal women with osteoporosis at high risk of fracture; and the BRIDGE study enrolled 245 men with osteoporosis.

The approval of Evenity in Japan was based on data from the FRAME and BRIDGE studies. Japan’s Pharmaceuticals andMedical DevicesThe Pharmaceuticals and Medical Devices Agency (PMDA) conducted a comprehensive review of the safety of Evenity, as well as the cardiovascular safety signals identified in the ARCH study.

Professor Satoshi Soen, Department of Orthopedic Surgery and Rheumatology, Nara Hospital, Kinki University, Japan, stated, “Evenity not only promotes bone formation but also reduces bone resorption and inhibits cortical bone porosity. The results demonstrate a significant increase in bone mineral density during the early phase after administration, and confirm a reduction in the incidence of vertebral fractures, non-vertebral fractures, and hip fractures. MultipleClinical Trialevidence suggests that Evenity can be used as a first-line treatment for osteoporosis patients at high risk of fracture, such as those with vertebral fractures or significantly reduced bone mineral density.”

Yukiya Suzuki, Sales Director at AABP, stated, “Japan is becoming a super-aged society, and fractures caused by osteoporosis are expected to increase further. This not only significantly impacts healthy life expectancy but also affects overall prognosis, as these fractures may necessitate long-term care and assistance. With its dual mechanism of action, Evenity significantly increases bone mineral density in a short period while simultaneously reducing fracture risk. We are delighted to offer Evenity to physicians and healthcare professionals in Japan as a new treatment option.”

Japan is one of the countries with the longest life expectancy globally, and it is estimated that by 2050, more than 37% of its population will be aged 60 or older. Age is one of the most common risk factors for osteoporosis, as bone mass decreases over time. Currently, there are approximately 12 million osteoporosis patients in Japan, and the incidence of hip fractures among individuals aged 75 and older has increased significantly in both men and women. (Bioon.com)

Original Source:EVENITY? SUBCUTANEOUS INJECTION 105 mg SYRINGE LAUNCHED IN JAPAN FOR THE TREATMENT OF OSTEOPOROSIS WITH HIGH RISK OF FRACTURE