FDA Accepts Lundbeck Resubmission of New Drug Application for Carnexiv™ (carbamazepine)

DEERFIELD, Ill.–(BUSINESS WIRE)–Lundbeck today announced that the U.S. Food and Drug Administration
(FDA) has accepted for review the resubmission of the New Drug
Application (NDA) for intravenous carbamazepine, 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.¹ 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.
About Lundbeck
Lundbeck is a global pharmaceutical company specialized in psychiatric
and neurological disorders. For more than 70 years, we have been at the
forefront of research within neuroscience. Our key areas of research
focus are depression, schizophrenia, Parkinson’s disease and Alzheimer’s
disease.
An estimated 700 million people worldwide are living with psychiatric
and neurological disorders and far too many suffer due to inadequate
treatment, discrimination, a reduced number of working days, early
retirement and other unnecessary consequences. Every day, we strive for
improved treatment and a better life for people living with psychiatric
and neurological disorders — we call this Progress in Mind.
Our approximately 5,300 employees in 55 countries are engaged in the
entire value chain throughout research, development, manufacturing,
marketing and sales. Our pipeline consists of several late-stage
development programs and our products are available in more than 100
countries. We have research centers in China and Denmark and production
facilities in China, Denmark, France and Italy. Lundbeck generated core
revenue of DKK 14.6 billion in 2015 (EUR 2 billion; USD 2.2 billion).
In the U.S., Lundbeck employs nearly 1,000 people focused solely on
accelerating therapies for brain disorders, including epilepsy. With a
special commitment to the lives of patients, families and caregivers,
Lundbeck U.S. actively engages in hundreds of initiatives each year that
support our patient communities.
To learn more, visit us at www.lundbeckus.com
and connect with us on Twitter at @LundbeckUS.
Source

1. Glauser T, Ben-Menachem E, et al. ILAE Treatment Guidelines:
Evidence-based Analysis of Antiepileptic Drug Efficacy and Effectiveness
as Initial Monotherapy for Epileptic Seizures and Syndromes. Epilepsia.
2006. 47(7):1094-1120.

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