Wyeth submits BLA for Prevnar 13

US drug major Wyeth Pharmaceuticals has submitted a Biologic License Application to the Food and Drug Administration for Prevnar 13,  pneumococcal 13-valent conjugate vaccine (diphtheria CRM protein).  Last year, the FDA granted the agent fast-track designation, which is  designed to facilitate review of products that address serious or  potentially life-threatening conditions for which there is an unmet  medical need. Prevnar 13 is designed to protect against the 13  most prevalent serotypes associated with pneumococcal disease, the  leading cause of vaccine-preventable death worldwide. Seven of these  serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevnar,  Wyeth's 7-valent PCV which is the current worldwide treatment standard.  The agent earned $2.7 billion last year.