Pharmaprojects R&D Pipeline News Feed
European approval for Synflorix
8 Apr 2009
Synflorix (formerly Streptorix) has been approved in the EU for the prophylaxis of invasive pneumococcal disease and acute otitis media caused by Streptococcus pneumoniae, in children aged between 6wk and 2yr. It consists of 10 pneumococcal serotypes, and incorporates a membrane protein from Haemophilus influenzae.
Synflorix is now set to compete head-to-head with Prevnar, a blockbuster vaccine developed by Wyeth and currently launched in more than 88 countries worldwide. It was first launched in 2000 in the US, and has gone on since then to reach the top spot as the world’s best-selling vaccine. The 10-valent design of Synflorix gives it an advantage over Prevnar, which is a heptavalent conjugate pneumococcal vaccine. This is set to change, however, once Wyeth’s 13-valent pneumococcal follow-up vaccine, Prevnar 13, is launched for the global prevention of serious pneumococcal disease and acute otitis media. Prevnar 13 was submitted for approval in the EU, as well as Iceland, Norway and Liechtenstein at the end of 2008, as well as in the US in Apr 2009.
In February 2009, GSK announced it might not launch Synflorix in the US, opting instead to focus on marketing it elsewhere in the world, where as it has greater competitive potential due to differing regional pneumococcal subtypes. So far it has not been submitted in the US, and may never be if GSK decide to maximise returns by marketing it heavily in Europe and elsewhere, before Prevnar 13 has a chance to impact this sector.
