US regulators have rejected Organon’s enzyme replacement therapy Livial (tibolone) for the treatment of menopausal symptoms in women, prompting the company – the human healthcare unit of Dutch concern Akzo Nobel – to withdraw its application in the country.
Commenting on the news, Toon Wilderbeek, General Manager of Organon, said: “Although Organon is disappointed with the FDA’s response, we will continue to be committed to this proven brand. Tibolone is available all over the world in countries outside the US where it has been approved and marketed for nearly 20 years.”
This is the second setback the drug has suffered this year. In January, the firm was forced to terminate its LIFT study of Livial - designed to investigate the effect of tibolone on new vertebral fractures in elderly osteoporosis patients - after an interim analysis showed that the drug increased the incidence of stroke.
Organon had hoped that an approval in osteoporosis would inject renewed vigour into Livial, which has seen its sales decline in the face of the general downturn in the HRT market that followed the release of the Women's Health Initiative study results showing HRT was associated with an increase in cardiovascular risk. Sales of Livial fell 6% to 164 million euros ($195m) in 2005.