Public Statement of Pfizer's Thelin EU Marketing Authorization Withdrawal - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Public Statement of Pfizer's Thelin EU Marketing Authorization Withdrawal



The EMA has issued a statement addressing the withdrawal of the marketing authorization for Thelin, which was voluntarily withdrawn in 2010 because of a risk of serious liver injury.

Back in August 2006, the European Commission (EC) awarded the orphan designated Thelin (sitaxentan) marketing authorisation in the EU. Used to treat adults with pulmonary arterial hypertension, the endothelin receptor antagonist increases capacity for physical activity. Sixteen EU Member States consequently marketed Thelin.

On 10 Dec, 2010, Pfizer announced that it would cease clinical trials of Thelin and initiated a voluntary withdrawal of the product in the EU, Canada and Australia. Pfizer based this decision on safety information obtained from clinical trials and post-marketing reports. In a press release, the company stated: “While liver toxicity is a known complication of the class of drugs to which Thelin belongs, a new potentially life-threatening idiosyncratic risk of liver injury with Thelin has been observed.” Indeed, the withdrawal followed information on two cases of fatal liver injury.

On 6 Jan. 2011, the EC issued a decision confirming the withdrawal of the marketing authorization of Thelin and the European public assessment report has been updated to reflect the change. The EMA made a public statement addressing the withdrawal on 2 Mar. 2011.

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
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
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Click here