FDA increases new drug approvals, but take a closer look

The FDA has approved 29 new drug applications (NDAs) through April, 2008.  This represents the highest NDA approval rate since 2000.   Last year, the FDA approved only 16 NDAs and the 10-year average is 24.  Good news for the pharma industry?

Maybe not.  10 of the 29 new approvals come from new manufacturers for existing drugs, approvals of drugs already marketed or new formulations of existing drugs.  In other words, only 19 new pharmaceutical drugs made it to to the market last year, compared to 13 a year ago.

New Molecular Entities (NMEs), or compounds that are not related to any existing drug, is a better measure than NDAs of new classes of therapeutics entering the marketplace.  NMEs represent entirely new drugs and treatment opportunities.  In the past year, only three NMEs were approved, matching the previous low mark reached in 2002.  Over the last ten years, the average NME approval rate was six per year.

Read more on this in the Genetic Engineering News.