On September 29, the CDE official website showed that the marketing application for ibandronate sodium tablets (Bonviva) has been accepted.
Ibandronate sodium is an anti-osteoporosis drug, which has a certain improvement and therapeutic effect on osteoporosis and bone pain. Ibandronate sodium belongs to the bisphosphonate class of bone resorption inhibitors, mainly by combining with hydroxyapatite in the bone, it can inhibit the dissolution and formation of hydroxyapatite, thereby producing an anti-bone resorption effect. It can also directly damage osteoclasts through cytotoxic effects, leading to osteoclast apoptosis at low concentrations.
What diseases can this medicine be used for?
– for the treatment of hypercalcemia caused by malignancies with or without bone metastases;
– Treatment of bone pain caused by osteolytic bone metastases of malignant tumors;
– Treatment of osteoporosis in postmenopausal women;
– Prevention of bone-related events (including pathological fractures, bone complications requiring radiotherapy or surgery) due to breast cancer bone metastases.
Previously, Bonviva has been approved for 2 clinical trials in China, and it is intended to be suitable for the prevention of bone-related events (including pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer with bone metastases, and the treatment of patients with increased fracture risk. Osteoporosis in postmenopausal women.
The existing ibandronate sodium drugs approved for marketing in China are all in the form of injections, and Bonviva may become the first approved oral ibandronate sodium in China.
In 2005, Bonviva was approved in the United States for the treatment and prevention of osteoporosis in postmenopausal women. This tablet (150mg) only needs to be taken orally once a month. In 2017, Atnahs Pharma acquired the rights to the drug from Roche in all territories except the U.S. and Japan.
In addition to Bonviva in tablet form, Atnahs Pharma also has an ibandronate sodium injection (Bondronat). In 2019, Bondronat was launched in China and is indicated for pathological (abnormal) elevation of blood calcium (hypercalcemia) caused by tumors.
Studies have shown that Bonviva taken by mouth monthly is more effective in increasing bone density in the spine and hip than ibandronate in the form of an injection or a 2.5mg tablet taken daily. From a safety point of view, the most common adverse reactions reported by patients were arthralgia and flu-like symptoms.