Paraxel’s report, The US Drug Approval Trends and Yearbook 2008/2009, shows that a total of 28 new molecular entities (NMEs) were filed with the Food and Drug Administration (FDA) last year, up from 21 the previous year.
Parexel suggested that the increase in applications will be seen as an indication that higher R&D investment is beginning to pay dividends, particularly considering that, as of July last year, the FDA had only received seven such filings and was predicting a record low.
In the past decade, there has been a general, well-known, industry trend of increasing research and development (R&D) costs not being reflected in the number of new drug approvals.
A recent US Government Accountability Office report revealed that between 1993 and 2004, R&D spending went up 147 per cent to $40bn (€29bn) but the number of NDAs increased by only 38 per cent. Most of those were for modifications to existing drugs; the number of NME applications only increased seven per cent.
It can also be argued that the higher number of NME submissions are linked to the increased use of contract research and manufacturing by the pharmaceutical industry in recent years. Drug firms have begun employing such strategies to help boost development pipeline capacity and reduce the financial risks associated with developing a new product.
Mark Mathieu, Parexel’s director of publications, explained that: “NME and NAS approvals are key measures of new drug productivity in the biophamraceutical industry and these measures tend to improve based on the volume of new drug submissions.”
“The recent increase in the number of NME submissions is an encouraging sign. NMEs are a closely watched category because they are medicines that have never before been approved for any use,” added Mathieu.
He went on to say that: "Our analysis also shows that record percentages of drug marketing applications that the FDA has designated as priority submissions are going straight to approval in the first review cycle."
On a more negative note for innovative drugmakers, the FDA granted just 16 new drugs marketing approval.