New FDA Approvals in 2013

As in previous years, an article in the February issue of Nature Reviews Drug Discovery reports on the pharmaceuticals approved by the U.S. Food and Drug Administration in 2013 (Mullard, Nat Rev Drug Discov 2014; 13: 85-89; see also the respective report for 2012 in my post of February 28th, 2013).

The FDA has approved 27 new drugs in 2013. Although this is a drop by 31% compared to the previous year (39 approvals in 2012), it corresponds to the average since 2003 (26 new approvals per year). The largest share of new approvals again have drugs from oncology (30%), followed by compiunds for metabolic or endocrine disorders (11%). There were two approvals for neurological diseases (7%) and one (4%) for a psychotropic drug. The latter is vortioxetine (Brintellix®), about which I reported here on several occasions (see my posts of October 3rd, 2013, and of January 15th, 2014). Vortioxetine was also approved by the EMA, and its market entry in the EU is expected soon.

For neurological disorders, two compounds were approved: Dimethyl fumarate (Manufacturer: Biogen Idec) for the treatment of multiple sclerosis and eslicarbazepine (manufactured by Sunovion) for the treatment of epileptic seizures with partial onset. Analysts see dimethyl fumarate as a drug with blockbuster potential, since the compound is only the third orally administered treatment of multiple sclerosis, and it is also well tolerated. Dimethyl fumarate has been an approved treatment of psoriasis in Germany for a long time.

The approval of flutemetamol F-18 (Manufacturer: GE Healthcare) is of further interest for the clinical neurosciences. It is a PET radioligand for the quantification of amyloid plaques in the diagnosis of dementia of Alzheimer’s type.

About 30% of applications for authorization were initially rejected. Among the drugs rejected by the FDA were cariprazine (D3/D2 partial dopamine agonist for the treatment of schizophrenia and bipolar disorder, see my post of April 19th, 2013) and suvorexant (orexin receptor antagonist for the treatment of insomnia, see my post of April 27th, 2013).

Thus, 2013 was another year with only modest progress in the field of neuropsychiatric drugs.


This post is also available in: German

Please leave a comment!