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news.Amag Pharmaceuticals has announced that its European partner, Guerbet of France, has withdrawn its European marketing authorization application for Sinerem, known as Combidex in the US.
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Guerbet submitted a marketing authorization application (MAA) to the European Medicines Agency (EMEA) in November 2006 seeking marketing approval for Sinerem for the detection and characterization of metastatic lymph nodes in patients with pelvic cancer.
According to Guerbet, the Committee for Medicinal Products for Human Use (CHMP) indicated that the Phase III data submitted by Guerbet does not provide sufficient statistical demonstration of the efficacy of Sinerem. Guerbet stated that it plans to evaluate all possible options that would satisfy the EMEA’s requirements for the proposed indication.
Amag has granted Guerbet an exclusive right to manufacture and sell Sinerem in certain countries in Europe and other parts of the world.