BRIEF—Data from Phase III study to support 2018 filing for Edirol in China

Tokyo’s Chugai Pharmaceutical has released new data from a Phase III study of Edirol (eldecalcitol), an active vitamin D3 derivative in development for the treatment of osteoporosis.

Data from the China-based study show the candidate “significantly increased the bone mineral density (BMD) of osteoporosis patients compared with alfacalcidol,” and that it has a safety profile consistent with previous reports.

The company says it is in discussions with the China FDA about submitting for regulatory approval there in 2018. The country is thought to have 69 million osteoporosis patients.

Edirol has been widely used in Japan since launching in 2011.