China FDA to review Chugai's regulatory submission for Edirol

22 March 2018

Shares in Japanese drugmaker Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Roche (ROG: SIX), are up almost 5% on news that the China Food and Drug Administration (CFDA) is to consider the firm’s regulatory application for eldecalcitol, an osteoporosis treatment marketed in Japan as Edirol.

Eldecalcitol is an active vitamin D3 derivative, which the firm tested in a China-based Phase III study, results from which were released late last year.

In that trial, patients who received eldecalcitol showed a statistically significant increase in bone mineral density, compared with those who received alfacalcidol. The safety profile was consistent with those seen in previous reports.

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