Lundbeck's Carnexiv gets FDA orphan drug status

DEERFIELD - Lundbeck announced the U.S. Food and Drug Administration has approved Carnexiv injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible.

Carnexiv received orphan drug designation for the indication and will be the first available intravenous formulation of the antiepileptic drug (AED) carbamazepine. Lundbeck plans to make Carnexiv commercially available in the United States in early 2017.

Carnexiv is a short-term intravenous replacement therapy for oral carbamazepine formulations that provides continuity of care for adult patients who are unable to take carbamazepine by mouth and have the following seizure types:

As with the oral carbamazepine formulation, there is a risk of serious dermatologic reactions during treatment with Carnexiv, including toxic epidermal neurolysis and Stevens-Johnson syndrome, as well as a risk of aplastic anemia and agranulocytosis.