Home » News » 12/05 » Johnson and Johnson and PharmaMar submit Yondelis to EMEA

Johnson and Johnson and PharmaMar submit Yondelis to EMEA

Date published: 20/12/2005

PharmaMar has announced that it will submit the soft tissue sarcoma (STS) drug Yondelis, developed with Johnson & Johnson, to the European Medicines Agency (EMEA). The company said that an independent data monitoring committee (IDMC) had reviewed interim data from the STS-201 trial, which looked at the effectiveness of two different dosing schedules of the drug ? weekly and 24 hour.

The review found that 24 hour dosage was more effective, and that it produced no toxic side effects. It has now allowed weekly users to move to the 24 hour regime. Yondelis claimed it had held a pore-submission meeting with the EMEA to discuss plans for a market authorisation application (MAA) and that it had already presented a letter concerning its intent to file for the indication.

PharmaMar's CEO Isabel Lozano said in a statement: "PharmaMar and J&J PRD continue to work diligently with the regulatory authorities towards submission for potential approval of Yondelis in STS as well as to develop the compound in other indications." Yondelis is also being studied in a phase III ovarian cancer trial.

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