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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Report on 2013 NMEs Downplays Approval Drop

Jan. 17, 2014

The FDA has published a report showing that it approved 27 new molecular entities (NME) in calendar year 2013, in line with its 2004–2012 average. Of those NMEs, a full 24 were first-cycle approvals and 20 were approved for the first time anywhere in the world.

The report acknowledges that the 2013 approval numbers represent a drop from the 2012 numbers (39), but claims that this can be explained by fewer NME submissions, which comprise both NDAs and BLAs submitted in 2013 — 32 by Nov. 30, 2013, as compared to 41 in 2012.

Of the 27 approved in 2013, however, approximately half — 13 of 27 — were given some sort of expedited approval pathway:

  • Nine out of 27, or 33 percent, were orphan drugs;
  • 10 out of 27, or 37 percent, were given fast-track status;
  • Three out of 27, or 11 percent, were designated as breakthrough therapies;
  • 10 out of 27, or 37 percent, were given priority review; and
  • Two out of 27, or seven percent, were given accelerated approval.

Particularly noteworthy is the fact that many of the NMEs were approved before their original PDUFA dates. The report cites Genentech’s Gazyva (obinutuzumab) as having been approved in 6.3 months, Janssen’s Imbruvica (ibrutinib) in 4.5 months and Bayer’s Xofigo (radium RA 223 dichloride) in just five months. Average review times tend to be around 10 months.

View the report at www.fdanews.com/ext/resources/files/01/01-17-14-NMEApprovals.pdf. — Lena Freund

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