Akzo seeks better US labeling for Xyvion

Akzo Nobel has received US Food and Drug Administration approval forXyvion (tibolone) for the treatment of osteoporosis, but has said it will not launch it yet because it is not satisfied with the approved labeling. Tibolone, which is marketed in the UK under the brand name Livial and currently sold in about 70 countries, was expected to be launched in the USA in mid-2001 after a previous delay following discussions with the FDA over the labeling (Marketletter May 1, 2000).

Akzo told the Marketletter that it had hoped to differentiate its product from others on the US market, notably the bisphosphonates, led by Merck & Co's Fosamax (alendronate), and estrogen replacement therapies. Both of these classes have significant side effects, noted the spokesman; the first causes irritation to the esophagus and gastrointestinal tract and the second may restore the menstrual cycle in post-menopausal women. Tibolone is a synthetic steroid compound which combines endocrine and central nervous system effects and restores bone mineral density without the side effects which characterize its competitors, according to the firm.

Akzo noted that it is still in discussion with the FDA but added that it hopes to introduce the product there "as soon as possible."