Development history of alendronate sodium

Osteoporosis is a worldwide health problem, which attracts more and more attention. At present, there are about 200 million people suffering from osteoporosis in the world, and its incidence has jumped to the seventh place in common diseases and frequently-occurring diseases. At present, China has entered an aging society, and the prevention and treatment of senile diseases, especially osteoporosis, has become an important research topic. Senile osteoporosis is a common and frequently-occurring disease in the elderly, especially in postmenopausal women. Therefore, drugs for the treatment of osteoporosis have also attracted much attention and attention.

There are basically two kinds of drugs to prevent and treat senile osteoporosis, namely calcitonin drugs and estrogen drugs. Calcitonin is expensive and difficult to popularize in China. Long-term use of estrogen has certain side effects, and estrogen can not restore lost bone tissue. Bisphosphonate is a new drug developed in recent twenty years, and its prevention and treatment of senile osteoporosis has attracted foreign attention. Its clinical application has the following characteristics: ① it can not only inhibit bone resorption, but also increase bone mass and restore lost bone tissue; ② It can promote trabecular bone reconstruction and reduce the depth of resorption lacuna; (3) short-term medication, long-term effect. In addition, bisphosphonates are also the first-line treatment drugs for hypercalcemia caused by malignant tumors and bone diseases in paget.

Alendronate was invented by Gentili Institute in Italy, and it was marketed in Italy under the trade name Alendros at 1993, and in the United States under the trade name Fosamax at 1995. It is used to treat osteoporosis and osteoporotic osteitis. In May 1997, FDA approved its expanded indication for preventing osteoporosis and fracture again. Became the first non-hormonal drug approved by FDA to prevent osteoporosis. The weight gain effect of alendronate sodium is similar to that of estrogen and superior to calcitonin, which can significantly increase bone mineral density and reduce the incidence of fracture. It is effective and lasting after oral administration, with good tolerance and high safety.

Alendronate sodium in bisphosphonates is one of the products with good performance in the global market. 1.99 After the sales exceeded 1 billion USD, the performance rose steadily. In 2000, FDA approved the additional treatment of male senile osteoporosis, which prompted the product to heat up. In 2002, Fushanmei ranked the best-selling drug in the world with 18, with sales of $2.25 billion. Global sales reached $3.2 billion in 2005. Due to the expiration of the patent, this product will continue to grow internationally, but its share will decrease. However, it is a growing variety in China and should have a good profit rate.