(Reuters) - European regulators recommended approval of Pfizer Inc's Prevenar 13 vaccine for immunization of adults aged 50 years and older against pneumococcal disease.
Recommendations for marketing approval by the London-based Committee for Medicinal Products for Human Use are normally endorsed by the European Commission within a couple of months. The agency posted the letter, dated Sept. 22, on its website.
In July, the U.S. Food and Drug Administration extended its review of the vaccine, known as Prevenar in the United States, for the same patient group.
Prevenar 13 was approved for infants and young children in Europe in December 2009 and in the United States in February 2010. It is currently approved for that use in more than 100 countries.
"This definitely expands the patient population for the vaccine, but I think a majority of sales is still going to come from the infant population," said Morningstar Inc analyst Damien Conover.
Pneumococcal disease, which can cause pneumonia, meningitis and sepsis, is one of the world's biggest killers of children, claiming up to 1.6 million lives a year.
Prevenar 13 generated global second-quarter sales of $821 million, making it Pfizer's fourth-biggest product. It is poised to become the company's biggest brand after cholesterol fighter Lipitor begins facing U.S. generic competition in November.
Sales of Prevenar 13 could reach $5.83 billion in 2015, according to forecasts compiled by Thomson Reuters Pharma.
Pfizer acquired rights of the vaccine from its purchase of rival U.S. drugmaker Wyeth in late 2009.
