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EXUBERA RECEIVES POSITIVE OPINION FROM CHMP FOR THE TREATMENT OF TYPE 1 AND TYPE 2 DIABETES

October 14, 2005

Sanofi-aventis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of EXUBERA (insulin human), an inhalable form of insulin, for the treatment of type 1 and type 2 diabetes. The proposed therapeutic indication for Exubera is for the treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic agents and requiring insulin therapy; and for the treatment of adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns.

Läkemedelsindustriföreningen (http://www.lif.se/media/Pressmeddelande_LM/2005/Sanofi-aventis/Sanofi_05_10_14.asp)