EuroGen Pharmaceuticals Withdraws Its Application For Orathecin For Treatment Of Metastatic Pancreatic Cancer, Europe

Main Category: Pancreatic Cancer
Article Date: 25 Jan 2006 - 0:00 PDT

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The European Medicines Agency has been formally notified by EuroGen Pharmaceuticals Ltd of its decision to withdraw its application for marketing authorisation for the medicinal product Orathecin (rubitecan).

EuroGen Pharmaceuticals Ltd submitted an application for marketing authorisation to the EMEA on 1 July 2004. At the time the withdrawal has been made, it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP). The indication applied for was the treatment of patients with advanced or metastatic pancreatic cancer.

The CHMP has raised a number of major concerns relating to Orathecin and, based on the data currently submitted by the company, the Committee considers that the overall risks of the product were higher than the benefits to patients. The company informed the Agency on 19 January 2006 that it could not address at this stage the issues raised by the CHMP and has decided to withdraw its application.

A 'question and answer' document will be published on the EMEA website, together with the company's letter of withdrawal, after the next CHMP meeting on 23-26 January 2006.

1. This is the first publication of a withdrawal of a marketing authorisation application under the revised EU pharmaceutical legislation. The legal basis for the publication of this withdrawal is Article 11 of Regulation (EC No 726/2004.

2. Withdrawal of an application does not prejudice the possibility of a company to make a new application at a later stage.

3. This press release, together with other information about the work of the EMEA, may be found on the EMEA website: http://www.emea.eu.int

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