Orion to withdraw Simdax NDA

Orion Corp has said that it intends to withdraw its New DrugApplication for Simdax (levosimendan), which is filed with the US Food and Drug Administration, and will submit a new application containing additional data. The company originally filed for approval of Simdax in the treatment of decompensated heart failure at the end of last year, but the new dossier will contain additional data on "important product indications," AFX News reports. Orion's international marketing partner for Simdax is Abbott Laboratories. Levosimendan acts via a novel mechanism, increasing the sensitivity of the heart to calcium. Clinical data with the drug suggest that it can increase the heart's pumping ability without stimulating arrhythmia or increasing its consumption of oxygen.