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news.The FDA has requested more information from Novartis before it will approve the Swiss company's marketing application for Aclasta in Paget's disease.
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Novartis said that it is confident that providing the requested additional information to the FDA will help obtain final approval by the end of 2006. Aclasta has already been approved in 41 countries worldwide, including the EU, for the treatment of Paget’s disease.
This is the second approvable letter Aclasta has received in this indication. In this case, the FDA has requested additional data from the ongoing clinical trial program in osteoporosis.
The company said that submission of an application for marketing authorization for osteoporosis in the US and EU remains planned for 2007.
Paget’s disease is a chronic and sometimes painful disease of the bone affecting more than one million people in the US.