The FDA has accepted for review the resubmission of Lundbeck’s New Drug Application (NDA) for intravenous Carnexiv, an intravenous formulation of the anti-epileptic drug (AED) carbamazepine. An action letter is anticipated before the end of 2016. Lundbeck’s resubmission was in reply to the Complete Response Letter from the FDA issued in 2014 requesting additional data associated with the Chemistry, Manufacturing and Controls (CMC) of the product. The proposed U.S. trade name, Carnexiv, is under consideration with the FDA as well.
Oral carbamazepine is an important treatment option for people with epilepsy. However, intravenous carbamazepine formulations are currently not available for patients who are unable to take the medication by mouth. Intravenous carbamazepine received Orphan Drug designation from the FDA in 2013 and is proposed for use as replacement therapy in adults who are on a stable maintenance oral dose of carbamazepine to control certain seizure types, when oral carbamazepine administration is temporarily not feasible.
“As a company committed to helping people living with epilepsy, we have developed intravenous carbamazepine in the U.S. to address this unmet medical need,” said Daniele Bravi, chief medical officer, U.S. Drug Development. “Intravenous carbamazepine could provide a valuable option for those who temporarily cannot take their oral carbamazepine.”
“Lundbeck has worked diligently to address the FDA’s request for additional CMC data, and we are pleased that the FDA has accepted our file for review,” added Gregg Pratt, vice president of U.S. Regulatory Affairs.