FDA Pushes Back Prevnar Decision - Drug Discovery and Development

NEW YORK (AP) – Pfizer Inc. said that U.S. regulators will take another three months to consider approving its Prevnar 13 pneumococcal vaccine for use in adults.

Pfizer said the Food and Drug Administration now expects to make a decision by January 2012. The agency will use the time to consider additional data submitted by Pfizer that supports the use of the vaccine in adults age 50 and older.

Prevnar 13 is the world’s biggest-selling vaccine. It brought Pfizer $3.7 billion in worldwide revenue in 2010, and an expanded marketing approval would boost its sales. That would help make up for the loss of revenue from other products like the cholesterol drug Lipitor, which loses patent protection Nov. 30.

Prevnar 13 protects against 13 strains of pneumococcal disease, which can cause ear infections, meningitis and pneumonia. The FDA approved it in February 2010 for use in infants and young children. The vaccine was a key piece of Pfizer’s $68 billion acquisition of Wyeth in October 2009.

Date: July 29, 2011
Source: Associated Press