An inside look at the FDA's approach to speeding new drug approvals

Print 16 January 2015
John Carroll, FierceBiotech

The FDA enjoyed some industry kudos at the end of 2014 after handing out a record number of new drug approvals for the past decade. And now it's crunched the numbers for the year to underscore the kind of trends regulators see in the biopharma world.

The agency's Center for Drug Evaluation and Research (CDER) reported that two big groupings each accounted for 41% of the annual haul of NDAs: There were 17 first-in-class drugs that could boast significant advances for patients, and another 17 drugs that were specifically targeted against rare diseases.

The FDA has been promising to help drug companies get their products to the market earlier, and fully 66% of these drugs obtained some form of preferred treatment, including fast-track status and priority reviews. It was also no surprise to see that the number of breakthrough drugs spiked to 9 last year. These breakthroughs were designated for quick action at the agency, helping to quicken the R&D pace.

There was a sense early on that the agency favored the bigger developers in handing out the first round of BTD titles, and that was clearly reflected in the first big round of breakthrough approvals to come through. There was also a big emphasis on new cancer therapies, which accounted for 5 of the 9.

The FDA approved Blincyto (blinatumomab), Amgen's ($AMGN) new leukemia fighter that uses a bispecific T cell engager (BiTE) system to flag cancer cells for the immune system to destroy. Keytruda, the PD-1 immuno-oncology eye-catcher from Merck, got an OK alongside Bristol-Myers' ($BMY) rival Opdivo. Novartis ($NVS) won early FDA approval for the new "breakthrough" lung cancer drug ceritinib, launched as Zykadia. And Gilead ($GILD) also won an OK for Zydelig, its first-in-class PI3k inhibitor for blood cancers.

FDA cancer czar Richard Pazdur promised early on to embrace the BTD process, and he's begun to deliver. But IPF and hepatitis C also figured among the pioneering BTD drugs.

Esbriet, the IPF drug developed by InterMune, was snapped up by Roche ($RHHBY) just ahead of the approval. And it was approved the same day as Boehringer's Ofev. Harvoni, from Gilead, the big new hep C combo pill, was approved ahead of Viekira Pak from AbbVie ($ABBV), setting up a showdown in the marketplace.

The FDA also cited the 8 drugs that got an accelerated approval, as well as the 25 that obtained priority reviews, which sliced four months off the process.

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