US FDA expands Prevnar-13 approval
This article was originally published in Scrip
The US FDA has widened the approved indication for Pfizer's pneumococcal vaccine Prevnar-13 to include its use in patients aged 50 years and older.
The belated expanded approval comes after the agency extended the action date for the application by 90 days because it wanted more data from two studies included as part of the original sBLA; this was considered to be a major amendment to the filing (scripintelligence.com, 1 August 2011).
Prevnar 13 was already approved in the US in children aged between six weeks and five years for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. It is indicated in adults to prevent pneumococcal pneumonia and invasive pneumococcal disease caused by the 13 serotypes. In children it is indicated for the prevention of invasive disease caused by the 13 serotypes and for prevention of otitis media caused by seven of the serotypes.
The latest approval comes via the accelerated pathway because of the product's potential to help address a significant disease burden, and as such is subject to certain requirements. The vaccine has yet to show a reduction in pneumococcal pneumonia or invasive pneumococcal disease in adults in the clinic, and Pfizer is conducting the 84,000-patient CAPiTA (community-acquired pneumonia immunisation trial in adults) to fulfil this obligation. This trial is looking at whether Prevnar 13 is effective in preventing the first episode of community-acquired pneumonia caused by one of the 13 pneumococcal serotypes it contains.
Pfizer has also agreed as part of its post-marketing commitments to conduct a study to evaluate the concomitant use of Prevnar 13 and its annual trivalent inactivated influenza vaccine in adults aged 50 years and older who have been previously vaccinated with conventional pneumococcal polysaccharide vaccine (PPSV, Merck & Co's Pneumovax).
Data released last year showed that in adults Prevenar 13 was non-inferior to Pneumovax overall and was superior in some patient groups in preventing pneumococcal disease (scripintelligence.com, 10 May 2011).
The Pfizer vaccine is already indicated for use in adults over 50 years in a number of other markets, including the EU (where it is marketed as Prevenar 13), Australia, Mexico and more than 10 other countries, Pfizer says. Prevenar 13 was Pfizer's second best-selling product last year after Lipitor (atorvastatin) and is now poised to take the top slot. Sales of the vaccine in the third quarter 2011 topped $1 billion worldwide (up by 35%), but were down slightly in the US at $454 million, which Pfizer attributed to fewer paediatric patients receiving a catch-up dose as the timeframe for eligibility neared expiry.
Pfizer says there are about 440,000 cases of pneumococcal pneumonia in US over 50s each year.