Drug approvals by the US FDA’s Center for Drug Evaluation and Research reached a 15-year high last year, growing 33% to 39 new drugs, and consisting of 33 new molecular entities, up from 24 in 2011, and 6 new biological entities, the same as a year ago. Twenty of the drugs were first in-class agents. A third of the new approvals were oncology drugs, with almost all of them having been designated for fast-track or priority review. Among the cancer drugs approved was the first Hedgehog pathway inhibitor (Genentech/Curis’s Vismodegib). A third of the approvals were for orphan drugs, of which six were cancer drugs. Companies receiving their first drug approvals were responsible for 16 of new approvals. Five of the new approvals are estimated to eventually each have sales of more than a million dollars over a five-year period. Other drugs approved included the first drug designated a “breakthrough drug” (Vertex’s ivacaftor), meaning that it provides a notable benefit compared to existing therapies; the first biologic manufactured using a plant-cell system (Pfizer’s taliglucerase alfa); the first antibacterial monoclonal antibody to be approved (Human Genome Sciences’ raxibacumab); and the first agent in a new class of anti-tuberculosis drugs (Janssen’s bedaquiline).

Source: Nature Reviews Drug Discovery