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Home Industry News Wyeth presents positive data for osteoporosis drug

Wyeth presents positive data for osteoporosis drug

20th September 2007

Wyeth has presented data for bazedoxifene following a three-year study for the investigational therapy for osteoporosis.

The phase III fracture data was displayed at the American Society for Bone and Mineral Research Annual Meeting and showed that bazedoxifene 20mg and 40mg significantly reduced the relative risk of new vertebral fractures by 42 per cent and 37 per cent, respectively, compared with the placebo.

In addition, a post-hoc subgroup analysis of women at high fracture risk demonstrated that bazedoxifene 20mg significantly reduced the incidence of non-vertebral fracture by 52 per cent.

Wyeth also reported that a non-statistically significant increase in the incidence of venous thromboembolic events was observed in all active treatment groups compared with the placebo group however there were no safety concerns related to the reproductive system.

In April this year, Wyeth received an approval letter for its pending new drug application for bazedoxifene for the prevention of postmenopausal osteoporosis by the US Food and Drug Administration (FDA).

Wyeth then submitted a separate new drug application to the FDA for bazedoxifene in July, with the company declaring at this week’s presentation that the efficacy data for bazedoxifene represents only a portion of the safety and efficacy data that the company has submitted to FDA.

OnMedica reports today that the British Orthopaedic Association has called for all patients older than 50, who have had a fracture, to be routinely tested for osteoporosis.

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