Search is Powered by Google
Prostate / Prostate Cancer News

Pharmion Ltd Withdraws Its Marketing Authorisation Application For Orplatna (satraplatin), Europe

Main Category: Prostate / Prostate Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 05 Aug 2008 - 13:00 PDT

email icon email to a friend   printer icon printer friendly   write icon view / write opinions   rate icon rate article
Current Article Ratings:

Patient / Public:not yet rated

Health Professional:not yet rated

Article Opinions: 0 posts

The European Medicines Agency (EMEA) has been formally notified by Celgene Europe Ltd of Pharmion Ltd's decision to withdraw the application for a centralised marketing authorisation for the medicine Orplatna (satraplatin) 10 mg and 50 mg capsules. Orplatna was expected to be used, in combination with prednisone and prednisolone, in the treatment of patients with metastatic hormone-refractory prostate cancer who have failed prior chemotherapy.

The application for marketing authorisation for Orplatna was submitted to the EMEA on 22 June 2007. At the time of the withdrawal, it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).

In its official letter, the company stated that the withdrawal of Orplatna was based on the CHMP's view that the data provided do not allow the Committee to conclude a positive benefit-risk balance for Orplatna for the applied indication.

More information about Orplatna and the state of the scientific assessment at the time of withdrawal will be made available in a question-and-answer document. This document, together with the withdrawal letter from the company, will be published on the EMEA website in due course.

Notes

1. Pharmion Ltd was acquired by Celgene Europe Ltd in March 2008.

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

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

European Medicines Agency




Customized Homepage Weekly Newsletters Daily News Alerts
Home About Us News Licensing Free Website Feeds Free Tools & Content Links Tell a Friend Accessibility Help / FAQ Article Submission Contact Us
Urology
ADHD Autism Diabetes

add medical news today to your facebook

medical news gadget

Add to Google


developers
website gadget code
website news code
medical news rss feed links


customize your homepage


These are the most read articles from this news category for the last 6 months:
Top Article Star
Prostate Cancer Drug Breakthrough For Aggressive Form Of Disease
22 Jul 2008
A new trial drug called abiraterone has shown a high success rate at treating men with an aggressive, drug resistant, and often fatal form of prostate cancer. 70 to 80 per cent of the men on the trial experienced dramatic...


Talking with Your Doctor image Talking with Your Doctor

Talking with your doctor can sometimes be difficult. Good health care, however, depends on an open dialogue between patients and doctors...

Improving Health Care image Improving Health Care

Improvements are necessary to make sure Americans get the best quality health care and that money for this care is being spent as effectively as possible. Listen as experts -- both in government and in the private sector -- describe some of the steps taken to improve the health care system...

View more videos...