FDA approvals for first half of 2013

The US Food and Drug Administration (FDA) approved 13 new therapeutics in the first 6 months of the year.

The lowdown: Between January and June this year, the FDA approved 13 new molecular entities (Table 1). This tally is similar to the number approved in the first half of 2012, in which the total number of approvals soared to 39: a 15-year high for the FDA.

Table 1 New molecular entities approved by the FDA: January to June 2013

Notable approvals include ado-trastuzumab emtansine, an antibody–drug conjugate (ADC) indicated for HER2-positive metastatic breast cancer, which is the second recent approval in a new wave of cancer therapies based on ADC platforms (Nature Rev. Drug Discov. 12, 329–332; 2013). Meanwhile, the antisense platform technology received a boost from the approval of mipomersen for the rare genetic disorder homozygous familial hypercholesterolaemia (Nature Rev. Drug Discov. 12, 179; 2013).

Canagliflozin became the first sodium-dependent glucose co-transporter 2 (SGLT2) inhibitor to be approved in the United States (Nature Biotech. 31, 469–470; 2013), and trametinib became the first drug that targets MEKs (MAPK/ERK kinases) to be approved (Nature Rev. Drug Discov. 11, 819–820; 2012).