Novel new drugs approved in 2014

FDA’s Center for Drug Evaluation and Research (CDER) reports that it has approved 35 novel new drugs in 2014. These 35 drugs include new molecular entities (NMEs) submitted to CDER in new drug applications (NDAs) and new therapeutic biologics submitted in biologics license applications (BLAs).

Among this total of 35 novel new drugs, which is up from the total of 27 approved in 2013, are 7 breakthrough NMEs and 15 orphan NMEs. The 15 orphan NMEs constitute the highest total for these drugs since the passage of the Orphan Drug Act in 1983.

The drug innovation record has been strong in 2014. Four (43%) of every 10 novel drugs approved are indicated for the treatment of rare diseases that affect 200,000 or fewer persons in the United States; this translates into a record 15 approvals. Previously, the record was 13 approvals for rare diseases in 2012. There were also 15 approvals that are first in their class of drugs. Further, 23 (66%) of the 35 new drugs approved this year have been made available to patients in the US prior to their availability to patients in Europe.

Another notable statistic out of this year’s drug approvals is that 10 new biologics are among this group, with these BLAs accounting for 29% of all new drug approvals. Biologics continue to drive the global growth in new drugs under development.

The CDER report notes that antibacterial agents, an area of drug development which has proved among the more challenging, accounted for 3 new drugs in the group of approvals this year. These agents are dalbavancin (Dalvance, Durata Therapeutics), tedizolid phosphate (Sivextro, Cubist Pharmaceuticals), and oritavancin (Orbactiv, The Medicines Company), and are approved to treat acute bacterial skin and skin structure infections. This number for 2014 is in contrast to a total of only 5 new systemic antibacterial drugs approved from 2004 through 2013.

Drugs in Perspective: Dalvance

Other examples of highlights among this year’s novel drug approvals include blinatumomab (Blincyto, Amgen), which is for the treatment of patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, and ledipasvir/sofosbuvir (Harvoni, Gilead Sciences), an oral combination tablet, which is for the treatment of chronic hepatitis C virus genotype 1 infection. Both of these drugs have the potential to more effectively help patients suffering from these illnesses.

Prescription Drug User Fee Act (PDUFA) goal dates for the approval review cycle were met by 34 (97%) of the 35 novel drugs, and approximately 74% of the novel drugs were approved in the first review cycle. Over half (57%) were approved under priority review, and 37% received fast track designation. In general, fast track, priority review, accelerated approval, and the new breakthrough therapy designation have helped get these novel new drugs more quickly approved and available to patients who could benefit from them.

The CDER New Drug Review: 2014 Update was presented on December 11, 2014. For a complete list of the new NMEs and BLAs approved by CDER in 2014, go to: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/default.htm