Please login to the form below

Not currently logged in
Email:
Password:

Blow for Wyeth Tygacil application

Wyeth Europa has withdrawn its application to approve Tygacil for extended uses in the European market.

Wyeth Europa has withdrawn its application to approve Tygacil for extended uses in the European market.

Tygacil (tigecycline) is currently approved for the treatment of complicated skin, soft tissue and intra-abdominal infections. Wyeth had hoped that the drug would be given further indication to treat patients with community-acquired pneumonia (CAP).

The Committee for Medicinal Products for Human use (CHMP) said not enough critically ill patients were included in pivotal trials to prove the drugs efficacy and safety, leaving reviewers unable to render an informed decision. Subsequently, Wyeth withdrew the application for extended marketing authorisation from the European Medicines Agency (EMEA).

Dr Gary Stiles, executive vice-president and chief medical officer of Wyeth Pharmaceuticals, said: "We are disappointed that we were not able to allay the concerns of the CHMP and are evaluating the appropriate next steps to take in Europe."

Wyeth filed a supplemental new drug application (ND) to the US Food and Drug Administration (FDA) in October 2007 for the same treatment indication. An FDA decision is expected in the second quarter of 2008 and outcomes of regulatory reviews are pending in Australia, Brazil, Canada, Switzerland and India.

"We believe that the clinical trial data submitted to the FDA, as well as other regulatory authorities around the world, demonstrate the safety and efficacy of Tygacil for the proposed CAP indication," Stiles concluded.

At present, Tygacil is approved for therapeutic use patients with CAP in the Philippines and Thailand.

25th April 2008

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Kendle Healthcare

Company founder Neil Kendle was a pioneer in opinion leader engagement. In 2003, Neil brought together a small, dedicated team...

Latest intelligence

50 questions for delivering an exceptional healthcare brand experience
Our 50-question brand planning checklist for healthcare ensures you deliver an exceptional experience, based on what your stakeholders want and need...
The brand strategy revolution
Introducing a new tool for developing a stakeholder-centric brand, based on the experience your patients and their HCPs want and need....
How Medisafe is using AI to improve patient adherence
Dina Patel speaks to Omri Shor, Co-Founder and CEO of Medisafe, to find out how his medication management app is tackling the problem of poor adherence....

Infographics