Chugai Pharmaceutical says eldecalcitol reduces new vertebral fractures

Chugai Pharmaceutical has announced that eldecalcitol, which is being co-developed by the company and Taisho Pharmaceutical, has been found to reduce the incidence of new vertebral fractures.

The product provides a “superior” effect when compared to bones treated with the existing and widely-used active vitamin D3 agent, Chugai explained.

Eldecalcitol’s phase II clinical trial began in 2004 and involved 1,087 patients each randomly allocated to receive an oral dose of either alfacalcidol or eldecalcitol once a day.

Those taking the later showed a lower incidence of fractures, with both groups being monitored for three years. No irregularities were observed and safety profiles were similar.

More detailed results are set to be published in the future, with regulatory filing scheduled for next year following collation of the data.

Earlier this month, Chugai revealed it had been given further guidance for its Biologics Licence Application for its humanised anti-human IL-6 receptor monoclonal antibody Actemra, which is a treatment for active rheumatoid arthritis.

The advice was provided by the US Food and Drug Administration.