Xofigo Injection Recommended for Approval in EU - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Xofigo Injection Recommended for Approval in EU



Algeta ASA reported that Bayer has received a positive opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) recommending approval of Xofigo (radium Ra 223 dichloride) in Europe. The proposed indication is for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. The decision of the European Commission on the approval is expected in the fourth quarter of 2013.

Xofigo injection was approved by FDA in May 2013 for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease and is now available in the US at licensed facilities.

In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of Xofigo. Under the agreement, Bayer will develop, apply for health authority approvals worldwide, and commercialize Xofigo globally. Algeta is eligible for royalties and milestones based on Bayer's sales of Xofigo outside the US, and Algeta US, is co-promoting Xofigo with Bayer in the US.

Source: Algeta ASA

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications

Click here