Although the company said it expected to file its regulatory applications in the U.S. and Europe next year, Wyeth announced Wednesday that it had submitted it's application to the EMEA for Prevnar-13 (PCV13), an enhanced version of its blockbuster vax Prevnar (marketed in Europe as Prevenar). The company is seeking approval to market the vax for children two months to five years old in the EU, Norway, Iceland and Liechtenstein. PCV13 received fast track designation from the FDA earlier this year and Wyeth's latest statement says it expects to complete its U.S. filing early next year.
The new investigational vax protects young children against 13 strains of bacteria linked to pneumococcal infections, whereas the version already on the market only protects against seven types of these bacteria. Data from four European studies presented in October showed that PCV13 offered better protection than Prevnar. Wyeth has had great success with Prevnar, which has brought in over $2 billion a year since it hit the market in 2000, and reduced the incidence of pneumococcal disease in children 5 and under by nearly 80 percent.
Global phase III trials evaluating the efficacy of PCV13 in adults are already underway, with regulatory filings expected in 2010, according to the company's statement.
- check out the Wyeth release