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2014 Drug Approvals: Speeding Novel Drugs to the Patients Who Need Them

Wednesday, December 17, 2014

Margaret A. Hamburg, M.D., commissioner of the FDA, spoke about 2014 drug approval data on the FDA’s official blog FDAVoice.

Based on preliminary data, 2014 was a strong year for novel drug approvals. The Center for Drug Evaluation and Research (CDER) has so far approved 35 novel new drugs in 2014 compared to 27 in 2013. These numbers include both new molecular entities (NMEs), submitted to CDER in New Drug Applications (NDAs) and new therapeutic biologics submitted to CDER in Biologics License Applications (BLAs).

Hamburg said, “So far this year we’ve reached a milestone with a record 15 approvals for rare diseases. The previous high was 13 drugs in 2012. These results are all the more significant because patients with rare diseases often have few or no drugs available to treat their conditions.

“And here’s another point of interest—to date, 15 of the approvals have been first in their class drugs, another indicator of their potentially strong clinical impact,” Hamburg continued. “To ensure that 2014’s novel drugs get to patients as quickly as possible, CDER effectively employed a variety of regulatory tools including FDA’s expedited development and review programs—Fast Track, Priority Review, Accelerated Approval and our new Breakthrough Therapy designation.”

Early and repeated communications with sponsors also have been helpful in speeding products to market. One example is Blincyto, which was recently approved to treat Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia. CDER employed all of its expedited review programs to help get this drug to market as early as possible, five months ahead of its review goal date. The sponsor also benefited from incentives for drugs that treat rare diseases.

“One of the more challenging areas of drug development has been the rather barren field of antibacterial drugs,” said Hamburg. “Among our 2014 approvals to date are three new antibacterial drugs—Dalvance, Sivextro and Orbactiv—to treat skin infections, specifically acute bacterial skin and skin structure infections (ABSSSI). These drug approvals represent a welcome but modest increase in activity in this product area. Prior to 2014, only five new systemic antibacterial drugs were approved during the period from 2004 to 2013.

Hamburg also said, “Thirty-four of the 35 drugs approved so far in 2014 were approved before or on their Prescription Drug User Fee Act (PDUFA) review goal date and 23 of the 35 drugs were available to patients in the U.S. before they were available to patients in Europe.”

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