BioWorld International Correspondent
BRUSSELS, Belgium - The European medicines agency has followed up on EuroGen Pharmaceuticals' withdrawal of its application for Orathecin with an information package explaining what was at stake.
In line with the agency's new policy of transparency with the public on regulatory matters, a statement explained how the product "is expected to work," what documentation had been presented to support the European application, how far the evaluation had progressed and what the main regulatory concerns were.
The agency stated that Orathecin (rubitecan) was being investigated in two main clinical studies of some 800 patients, assessing survival rates after receiving Orathecin in a comparison with standard medicines.
"Orathecin was given to the patients until their cancer progressed or they could not tolerate the treatment anymore," said the statement.
At the time of withdrawal, the application for Orathecin, designated an orphan product under European rules in June 2003 and under evaluation in Europe as an oral capsule for treatment of patients with advanced or metastatic pancreatic cancer, was 172 days into the 210-day process that the agency normally follows to evaluate a new application.
The agency said that "based on the review of the data and the company's response to the list of questions," the agency "had concerns and was of the provisional opinion that Orathecin could not be approved" for the indications that had been applied for. (See BioWorld International, Jan. 25, 2006.)
In the studies presented, "it could not be shown that Orathecin extends the life of patients nor improves their quality of life. Moreover, patients treated with Orathecin experienced many side effects, including serious ones," the agency said. Its view was that "the benefit had not been sufficiently demonstrated and did not outweigh the identified risks."
The company informed the agency that at the time of the withdrawal all clinical trials in the European Union had been closed and there were no ongoing compassionate-use programs.
But to reassure the EU public about the consequences of the withdrawal for patients, the agency statement added: "If you are in a clinical trial or compassionate-use program and need more information about your treatment, contact the doctor who is giving you the treatment."
The company withdrew its European application Jan. 19, shortly after the U.S. parent had done likewise to an application to the FDA.
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