GlaxoSmithKline Biologicals has been granted approval in the European Union for its Rotarix vaccine, which prevents gastroenteritis caused by rotavirus infection.
GSK Bio said Rotarix is the first rotavirus vaccine to reach the market in Europe, where the virus causes the hospitalisation of 87,000 babies and over 700,000 visits to the doctor each year. Approval was expected as Rotarix cleared a European Medicines Agency (EMEA) advisory panel a few weeks ago.
An earlier rotavirus vaccine, Wyeth’s Rotamune (sold as RotaShield in the USA), was approved in Europe in 1999, but had not started shipping before it was taken off the market around the world that same year, after being linked to a serious side effect known as intussusception, a twisting of the bowel.
GSK Bio said there is no evidence from its clinical trials that Rotarix causes intussusception.
Rotarix is one of five vaccines highlighted by GlaxoSmithKline as underpinning its vaccines business, which has emerged as a major new growth business for the group, along with cervical cancer vaccine Cervarix, Streptorix for pneumococcal disease, an improved vaccine for influenza and vaccine combinations against meningitis.
Together, these vaccines could address a market valued at $18 billion, according to GSK, which estimates the rotavirus vaccine market alone will reach upwards of £1 billion ($1.5bn) by 2010. Europe accounts for an estimated 20% of the global rotavirus vaccine market.
In addition to approval in the EU, an additional 33 licenses for Rotarix have been granted worldwide, including 16 in Latin American countries and Singapore in Asia. Rotarix is not approved in the USA, where rival product Rotateq from Merck & Co just won its license. GSK reiterated that is in late stage development discussions with the US Food and Drug Administration (FDA) regarding licensure of Rotarix.