NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) said Friday the US Food and Drug Administration has granted an expanded approval for its blockbuster drug Prevnar 13 to prevent pneumococcal disease in adults 50 years and older.
The expanded approval positions Prevnar 13 as the first pneumococcal conjugate vaccine in single dose for adults aged 50 and above to prevent pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae serotypes, the drug maker said.
Prevnar 13 was first approved by the US FDA in February 2010 for the prevention of invasive pneumococcal disease in infants and young children from 6 weeks through 5 years of age. It has also been approved for various indications in adults 50 years and older in the EU, Australia, Mexico and more than 10 other countries. In Pfizer's third quarter, the drug had worldwide sales of $1 billion, up 37 percent from last year.
'Pneumococcal disease, including pneumonia, in adults 50 years and older represents a significant personal and societal health burden in the United States. The FDA approval of Prevnar 13 for these adults offers the potential to contribute to the health of millions of aging Americans. This approval is representative of Pfizer's dedication to discovering and bringing to market life-changing medicines and vaccines,' said Pfizer CEO Ian Read.
Pneumococcal disease, or PD is a group of infections caused by the bacterium Streptococcus pneumoniae, also known as pneumococcus. The most common manifestation of PD in adults 50 years of age and older is non-bacteremic pneumococcal pneumonia, a non-invasive form of the disease. It is estimated that there are hundreds of thousands of Streptococcus pneumoniae infections per year, including more than 440,000 cases of pneumococcal pneumonia.
Pfizer's application to the FDA was based on safety and immunogenicity studies involving about 6,000 adults 50 years of age and older.
Pfizer is currently conducting the Community-Acquired Pneumonia Immunization Trial in Adults, or CAPiTA to fulfill requirements under the accelerated approval pathway. In addition, Pfizer has agreed, as a post-marketing commitment in connection with the approval, to conduct a study evaluating concomitant use of Prevnar 13 and TIV (annual trivalent inactivated influenza vaccine) in adults 50 years of age and older who have been previously immunized with pneumococcal polysaccharide vaccine, or PPSV.
PFE closed Friday's trade at $21.64, down $0.07 or 0.32%, on a volume of 26.7 million shares on the NYSE. In after hours, the stock gained 0.18%.
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