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Home Industry News Wyeth Pharmaceuticals receives approvable letter for osteoporosis treatment

Wyeth Pharmaceuticals receives approvable letter for osteoporosis treatment

27th May 2008

Wyeth Pharmaceuticals has been issued with an approvable letter from the US Food and Drug Administration (FDA) for its treatment of postmenopausal osteoporosis, bazedoxifene, the company has confirmed.

The letter requests information to build on the data Wyeth included in the New Drug Application for bazedoxifene.

This includes further analysis on the incidence of stroke and venous thrombotic events, as well as source documents and details concerning data collection.

Wyeth Pharmaceuticals executive vice-president and chief medical officer, Gary Stiles, said the FDA’s requests were “in line with our expectations”, adding that the company is working on a “complete response”, which it expects to file before the end of the year.

“We remain committed to pursuing bazedoxifene as an important new option for the millions of postmenopausal women at risk for osteoporotic fracture,” he added.

Bazedoxifene is an oestrogen receptor modulator designed to cut postmenopausal osteoporosis-related fractures, leading to improvements in overall health as well as reducing medical costs by shrinking the need for post-fracture treatments.

According to the World Health Organisation, osteoporosis-related fracture rates increase “rapidly” with age, with hip fractures – fatal in around 20 per cent of cases – being the most common. In 1990, its figures show there were 1.7 million hip fractures worldwide. This is expected to increase to six million by 2050.

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