Regulatory Focus™ > News Articles > FDA's Two-year Approval Record Marks 15-Year Best, Report Finds

FDA's Two-year Approval Record Marks 15-Year Best, Report Finds

Posted 06 December 2012 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has approved the same number of drugs during the 2012 fiscal year as it did in 2011, a new FDA report claims-the best two-year approval record in 15 years.

The agency's "Fiscal Year 2012 Innovative Drug Approvals" report notes that FDA has already "used expedited approval authorities and flexibility in advising sponsors on clinical trial design to approve 35 new novel drugs" this past fiscal year (1 October 2011 through 30 September 2012).

The approvals mark the second-highest number of approvals since 2004, when the agency approved 36 drugs. One a two-year cumulative basis, the agency's 2011 and 2012 numbers are the best since the late 1990's, when the agency approved 53 new biologic and molecular entities in 1996 and 39 in 1997.

Those drugs include a wide range of products meant to treat a host of cancers and conditions: Xeljanz (tofacitinib) to treat rheumatoid arthritis; Bosulif (bosutinib) to treat chronic myelogenous leukemia (CML), Zaltrap (ziv-aflibercept) to treat colorectal cancer and Kalydeco (ivacaftor)to treat a rare form of cystic fibrosis.

Twelve of the 35 drugs approved this year were pushed through the priority review pathway, which aims to get drug products through FDA's review processes within six months. The remaining 23 drugs were approved under a standard approval process.

FDA's report also provides insights other approval trends as well. With the exception of Avid Radiopharmaceuticals' Amyvid (florbetapir), used to estimate beta-amyloid plaque density, every other drug approved through FDA's priority review pathway received a first-round approval. In comparison, just 16 of the 23 drugs approved through the standard approval pathway won first-round approval.

FDA was also successful in getting the majority of the drugs it approved to market more quickly than its foreign regulatory counterparts. Of the 32 drugs FDA deemed eligible for a "first approved in the US" indication, 24 were first approved in the US. All but one of its priority review-approved drugs were approved first in the US. This number is up significantly from decades past. In 1985, for example, less than 5% of products were approved first in the US; in 2012, that percentage was 75%.

Sponsors of these products can also be thankful for another promising development: with the exception of EUSA Pharma's acute lymphoblastic leukemia (ALL) drug Erivedge (vismodegib), every single product (97%) met its target review date as established under the Prescription Drug User Fee Act (PDUFA), more commonly known as the product's PDUFA date.

"This report shows that FDA is still a leader in the quality and speed of its drug review and continues to make most innovative drugs available to patients earlier than other countries," FDA wrote.

The agency also touted its developments in the field of regulatory science in the report, noting that by "helping to streamline the phases of drug development that occur before a drug marketing application is submitted," regulatory science can help reduce the amount of time it takes for a product to obtain approval. With the exception of noting whether or not a product met its PDUFA date, FDA's report did not contain any information on the average time it took for products to obtain approval. The total time it takes for a product to obtain approval-from the date of submission to the time of approval-can differ significantly between two similar products even if both meet their respective PDUFA date goals.


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