GlaxoSmithKline&s Cervarix gets European panel nod

Share this article:

A European Medicines Agency (EMA) expert committee has issued a positive opinion of  GlaxoSmithKline's Cervarix.

The EMA panel's positive conclusion was based on data from clinical trials of Cervarix involving the vaccination of girls and women between the ages of 10 and 25 years old.

Recommendations for marketing approval by the EMA's Committee for Medicinal Products for Human Use are usually endorsed by the European Commission within a few months.

Glaxo hopes to launch Cervarix in Europe in the second half of 2007.
 
Cervarix is not likely to go on sale in the US until 2008, since Glaxo's FDA submission for the drug was not submitted until this March.

Cervarix won its first major approval in Australia in May.

Pending US and European approval, Cervarix faces competition in the form of Merck's Gardasil. Analysts have predicted that both drugs have multibillion-dollar-per year potential, with Gardasil having an early edge reaching the market in 2006.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...