Karyopharm Files MAA For Myeloma Candidate Selinexor In EU
Zacks Investment Research | Jan 08, 2019 09:45PM ET
Karyopharm Therapeutics Inc. (NASDAQ:KPTI) announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its oral selective inhibitor of nuclear export (SINE) compound selinexor. The company is seeking a conditional approval for selinexor regarding the treatment of patients with penta-refractory multiple myeloma (MM), having received at least three prior lines of therapy.
The MAA was based on positive results from the pivotal phase IIb STORM study, which evaluated selinexor in combination with low-dose dexamethasone on patients with penta-refractory MM.
Karyopharm also informed that the MAA has been granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the EMA. Under this procedure, the EMA’s active review time of the MAA is potentially reduced from 210 days to 150 after it is validated by the EMA. Notably, selinexor also enjoys an orphan designation for MM across the EU.
Meanwhile, the new drug application targeting an approval for selinexor in the United States is under priority review with a decision expected on Apr 6, 2019.
Shares of Karyopharm have inched up 1.7% in the past year against the Zacks Investment Research
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