Procter & Gamble's bisphosphonate drug Didronel PMO (etidronate disodiumand calcium) has been approved in the UK for the prevention of osteoporosis in post-menopausal women. It is the first non-hormonal drug to be approved for this indication in the UK, and was also cleared for the prevention and treatment of corticosteroid-induced osteoporosis.
The product was first approved in the UK in 1992 for the treatment of established osteoporosis, and this is the first country to approve it for prevention. P&G has made similar applications for the latter indication in France, Germany, Canada, the Netherlands, Italy and Sweden.
Risedronate Filing In 1998? P&G is also developing a new-generation bisphosphonate, Actonel (risedronate), which is in late-stage Phase III trials. The company says it plans to seek regulatory approval for Actonel in Europe and the USA in the second half of 1998, with other international filings planned thereafter.
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