Vortioxetine Approved in Europe

In my post of October 3rd, 2013, I had already pointed out that the American FDA had approved the new antidepressant vortioxetine. On December 18th, 2013, the European agency EMA followed this decision and approved the drug for use in the EU. I have already published a detailed substance characteristics. It is expected that vortioxetine will be available in the second quarter of 2014. The trade name is Brintellix®.

The pricing will be very interesting. Meanwhile, almost all antidepressants are available as generics. The manufacturers of Brintellix®, Lundbeck and Takeda, can initially set the price for their product freely. This applies to the first twelve months. Very soon, however, the Institute for Quality and Cost Effectiveness in Health Care (IQWiG) will assess whether there is an additional benefit of vortioxetine compared to the available – very cheap – compounds. Thus, in 2015 it will turn out, whether Lundbeck and Takeda can achieve the desired price for their product.

 

This post is also available in: German

One thought on “Vortioxetine Approved in Europe

  1. This so-called, “serotonin modulator and stimulator”, appears to have the same treatment and side-effect profile as SSRI’s

    US Label Last updated July 2014 after review in September, 2014. Versions of label are available at FDA index page Page accessed January 19, 2016. Prescribing info: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204447s004lbl.pdf

    Kelliny M, Croarkin PE, Moore KM, Bobo WV. Profile of vortioxetine in the treatment of major depressive disorder: an overview of the primary and secondary literature. Ther Clin Risk Manag. 2015 Aug 12;11:1193-212. PMID 26316764 Free full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4542474/

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