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Good news for the Hungarian pharmaceutical company Richter and all its shareholders: the U.S. Food and Drug Administration (FDA) has approved a product called Vraylar (cariprazine) as a treatment for Major Depressive Disorder (MDD). The drug was developed by the Hungarian company, Világgazdaság reported.
AbbVie, Richter’s US commercial partner, announced on Friday that the FDA has approved the drug for use as an adjunctive therapy to antidepressants for the treatment of MDD in adults. Efficacy and tolerability were demonstrated by clinical data submitted by AbbVie.
The active ingredient, cariprazine, was developed by Richter researchers and is the Hungarian-based company’s main product. It has already been approved in three indications in the United States. The new territory is expected to boost the product’s US sales, giving Richter a share of almost 20 percent, which will be reflected in the accounts as a net operating profit.
The announcement is also significant because it means that Vraylar is now the only antidepressant approved in the US to treat the most common forms of depression simultaneously. Moreover, the market for the product is not small, as MDD symptoms affect one in five US adults.
Dr. István Greiner, director of research and development at Gedeon Richter, said, “When we were in the early stages of developing cariprazine, we focused on designing a compound that would cover the symptom complex of mental illness and act on the dopamine D3 receptor.”
As reported on Concorde blog, a Hungarian economic site, GlobalData forecasts that by 2029, Vraylar will achieve sales of $741 million in the MDD market in the US, the five major European markets, Japan, and Canada. If this is indeed the case, Richter could expect at least $120 million in additional royalties from AbbVie.
Featured photo via Facebook/Richter Gedeon Nyrt.