New Drugs 2012

In the February issue of Nature Reviews Drug Discovery a brief overview of the new drugs, which have been approved by the Food and Drug Administration (FDA) in 2012, was published under the heading “2012 FDA drug approvals” (Mullard, Nat Rev Drug Disccov 2012, 12: 87-90). A total of 39 new drugs were approved, which is the highest number of new registrations since 1997.These are also about 33% more approvals than on the average of the last two decades. Particularly positive is that 20 of the new substances are true innovations (“first-in-class” agents).

One third (13) of the newly registered substances come from oncology. Other therapeutic areas with several new drugs are gastroenterology, pulmonology and infectious diseases. Substances against diseases of the CNS are listed quickly: teriflunomide (manufacturer: Sanofi) against multiple sclerosis, perampanel (Eisai) against certain forms of epilepsy and apixaban (Bristol-Myers Squibb) for stroke and systemic embolism in patients with atrial fibrillation. Particularly disturbing is that not a single new drug has been approved for a psychiatric disorder. One bright spot is merely florbetapir, a  PET radioligand labeled with fluorine-18 for the early detection of Alzheimer’s disease. The substance binds specifically to amyloid-β plaques. It was developed by Avid Radiopharmaceuticals, Philadelphia. This company was purchased in late 2010 by Eli Lilly for $ 800 million USD. Recently, the European Medicines Agency (EMA) also approved Florbetapir. Lilly is currently working on establishing a network that aims to ensure the supply of the radioligand.

A compound that could gain some relevance to psychiatry is lorcaserin (Eisai), a serotonin 5-HT2C receptor agonist. The substance has been approved by the FDA for the treatment of obesity. In 2010 the approval had been refused due to safety concerns. In Europe, the approval is pending. The FDA has also approved Qsymia (Vivus) 2012 in the same indication. The substance is currently available only online ( As a combination product of two already approved components (i.e., phentermine and topiramate), the preparation is not listed among the 39 newly registered entities. Phentermine is a stimulant, topiramate an anticonvulsant, in which weight loss is being observed as a side effect. In 2012, the EMA refused approval of Qsymia because of the risk of cardiovascular and central nervous system side effects and potential teratogenicity.


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