US FDA accepts lurasidone filing for schizophrenia
This article was originally published in Scrip
The US FDA has accepted for standard review Dainippon Sumitomo Pharma's (DSP) NDA for the atypical antipsychotic lurasidone, for the treatment of acute schizophrenia.
The filing was made ahead of the company's original schedule on December 30th, and incorporates data from over 40 clinical studies in more than 2,500 treated patients (scripnews.com, January 5th, 2010). DSP is looking to lurasidone to give a significant boost to its international business, and currently anticipates a US launch in the first quarter of next year.
A US filing is also planned next year for the additional indication of bipolar depression, and the company said recently that it was expecting total US revenues for lurasidone to exceed ¥50 billion ($555.5 million) within the next five years.
The molecule has a multiple mode of action, acting as a high affinity antagonist of dopamine D2, serotonin 5HT2a and 5HT7 receptors and also as a partial agonist of the serotonin 5HT1a receptor. It has minimal or no affinity for histamine H1 or muscarinic M1 receptors, which are linked to weight gain and cognitive impairment respectively.
DSP paid $2.7 billion last year to acquire Sepracor and its ready-made marketing infrastructure in the US, through which it intends to commercialise lurasidone. The Massachusetts-based firm is due to merge with DSP's US subsidiary on April 1st and will thereafter act as the Japanese company's US headquarters.