Teijin Pharma Receives Additional Approval in Japan for Abaloparatide Acetate as Treatment for Osteoporosis
Tokyo, Japan, September 5, 2022 --- Teijin Pharma Limited , the core company of the Teijin Group 's healthcare business, announced today that on August 31 the company obtained manufacturing and sales approval from Japan's Ministry of Health, Labour and Welfare for its abaloparatide acetate treatment OSTABALO ® Subcutaneous Injection Cart 1.5mg. The newly approved specification, which is for the treatment of osteoporosis, is expected to help promote bone formation in patients with high risk of bone fractures.
OSTABALO ® Subcutaneous Injection Cart 1.5mg, which Teijin Pharma has positioned as a strategic product for robust market penetration, is a new osteoplasty accelerator that embodies the company's extensive experience with treatments for bone and joint diseases.
The active ingredient in OSTABALO ® Subcutaneous Injection Cart 1.5mg is abaloparatide acetate, a polypeptide containing a modification of one part of the 34 amino acid sequences from the N-terminus of human parathyroid hormone-related peptide. Abaloparatide acetate selectively stimulates RG-type parathyroid hormone type 1 receptors involved in bone metabolism. Abaloparatide acetate is subcutaneously administered by aqueous injection (cartridge) once daily (80μg) for adults for up to 18 months. With once-daily subcutaneous administration, it is expected to promote bone formation that exceeds bone resorption through an increase in bone mass, and to prevent bone fractures.
The efficacy and safety of abaloparatide acetate have been confirmed in clinical trials in Japan and worldwide involving osteoporosis patients with a high risk of bone fractures. In April 2017, the U.S. Food and Drug Administration (FDA) granted approval to Radius Health, Inc. for the use of abaloparatide acetate in treating osteoporosis in postmenopausal women who are at high risk of fracture. For deployment in Japan, Teijin Limited, the parent company of Teijin Pharma, signed a license agreement with Radius in place for abaloparatide in July 2017 and the two companies have been partnering to develop and gain approval in Japan for OSTABALO ® .
According to a medical literature "2015 Guidelines for Prevention and Treatment of Osteoporosis," Japan is estimated to have about 13 million patients with osteoporosis, many of whom are at risk of bone fractures that could greatly reduce their everyday activity and quality of life. Osteoporosis is particularly troublesome for those with low bone density, bone fragility or a high frequency of fractures due to aging. There is strong demand in Japan for therapeutic drugs capable of increasing bone mass quickly to help patients avoid debilitating bone fractures.
Teijin Pharma is helping to improve patients' quality of life through solutions that address problems with bones and joints, including through the company's osteoporosis drugs ONEALFA ® and BONALON ® (*) and sonic accelerated fracture healing system SAFHS ® . Teijin Pharma is committed to enhancing patients' quality of life by providing new treatment options for diseases with high unmet needs.
Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the fields of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Originally established as Japan's first rayon manufacturer in 1918, Teijin has evolved into a unique enterprise encompassing three core business domains: high-performance materials including aramid, carbon fibers and composites, and also resin and plastic processing, films, polyester fibers and products converting; healthcare including pharmaceuticals and home healthcare equipment for bone/joint, respiratory and cardiovascular/metabolic diseases, nursing care and pre-symptomatic healthcare; and IT including B2B solutions for medical, corporate and public systems as well as packaged software and B2C online services for digital entertainment. Deeply committed to its stakeholders, as expressed in the brand statement "Human Chemistry, Human Solutions," Teijin aims to be a company that supports the society of the future. The group comprises some 170 companies and employs some 20,000 people across 20 countries worldwide. Teijin posted consolidated sales of JPY 926.1 billion (USD 7.2 billion) and total assets of JPY 1,207.6 billion (USD 9.4 billion) in the fiscal year that ended on March 31, 2022
Teijin Limited published this content on 05 September 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 September 2022 06:09:08 UTC.