31 July 1997 11:54 [Source: ICIS news]
LONDON (CNI)--Glaxo Wellcome said Thursday it has received approval from the UK Medicines Control Agency (MCA) to market Romozin (troglitazone) for the treatment of Type 2 (non-insulin dependent) diabetes.
This is the first regulatory approval for Romozin in Europe, said Glaxo, and the UK will now act as the reference member state under the European Commission's mutual recognition procedure.
Glaxo Wellcome said that Romozin differs from existing treatments for Type 2 diabetes as it is the first compound to target directly insulin resistance, the underlying cause of the disease.
Romozin has been developed by Glaxo Wellcome in Europe under licence from Sankyo, which discovered the compound. Glaxo Wellcome will market Romozin in Europe and other territories including South Africa and Israel. Sankyo has retained rights to market troglitazone in some European countries. Troglitazone is marketed as Rezulin by Parke-Davis and Sankyo in North America and as Noscal by Sankyo in Japan.
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