Article by BCG Senior Consultant, Michael Trapani, MS, MBA

Each year, the media covering the pharmaceutical industry reports on FDA’s performance statistics for approving new drugs and biopharmaceuticals.  Most of the attention is given to the approval of new molecular entities (NMEs) since these drugs, have not been previously approved by FDA. Occasionally, approval of a NME can provide a new treatment option for patients especially when there are few approved drugs available to address a serious disease or condition (often referred to as an unmet medical need).  These drugs are generally assigned priority review by FDA (≤ 6 months) whereas all other NME applications are assigned a standard review (≤ 12 months).  

Several news sources have recently reported that FDA approved twenty-four new molecular entities in 2008 as compared to eighteen NME approvals in 2007.  Although most reported that the number of NME approvals in 2008 increased by one-third as compared to approvals in 2007, there are several other interesting and important observations that should be noted.  This analysis provides a high-level review of the applications approved.  In a subsequent analysis, we will report on Phase IV commitments for approval.

Summary Findings:

1. Only two companies had more than one NME approved in 2008.
2. Three of the NMEs were submitted as BLAs, whereas, twenty-one were submitted as NDAs.
3. Ten of the twenty-four NMEs were approved during October-December, 2008 (Figure 1).
4. Eight NMEs were assigned priority review. Approved uses included treatments for cancer, HIV, thrombocytopenia, chorea, inflammation and pain associated with ocular surgery. 
5. Six of eight NMEs assigned priority review were also classified as orphan drugs.
6. One of the three BLAs approved was assigned a priority review.
7. Five of the NMEs were previously submitted to FDA prior to 2006.

Figure 1

Importance of reviewing FDA approval statistics.

When  preparing the regulatory strategy for the development of new drugs and biologics, its essential to understand the regulatory approval history of similar products or treatment uses so that the appropriate studies can be performed during the development cycle. Having a complete data package will obviously expedient the approval of your NDA/BLA but often will limit the amount of additional information required post approval. BCG consultants have extensive experience in product development and regulatory approval and can assist you in preparing, designing and executing your regulatory strategy.  For further information, please contact Michael Trapani at mtrapani@bcg-usa.com.

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