FDA denies Otsuka petition, approves Alkermes' Aristada
Alkermes plc (NASDAQ:ALKS) fell $1.27 to $58.50 amid a wider biotech sell-off on Tuesday, a day after FDA approved the company's Aristada aripiprazole lauroxil to treat schizophrenia. The drug is an injectable, extended-release formulation of aripiprazole using LinkeRx technology (see BioCentury Extra, Oct. 5).
FDA also denied a Citizen's Petition from Otsuka Pharmaceuticals Co. Ltd. (Tokyo, Japan) arguing that approval of Aristada should be denied or delayed until Otsuka's three-year exclusivity period for Abilify Maintena expires in December 2017. Abilify Maintena is a once-monthly intramuscular depot formulation of aripiprazole, a small molecule partial agonist of the dopamine D2 and serotonin (5-HT1A) receptors and antagonist of the serotonin (5-HT2A) receptor (see BioCentury Extra, July 16). ...