Norgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia

AMSTERDAM, March 26, 2024 /PRNewswire/ -- Norgine B.V. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia.

The European Commission (EC) will now review the CHMP's recommendation. If approved, the centralized marketing authorization would be valid in all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway and would be the first new treatment in Europe for malignant hyperthermia in over forty years. Submissions to the UK MHRA and Swiss Medic are ongoing.

Dr David Gillen, Chief Medical Officer of Norgine, added: "We are delighted to have received a positive CHMP opinion for NPJ5008. Malignant hyperthermia (MH) is thankfully a rare medical emergency following anaesthesia. Nevertheless, it is clear that effective management of MH is critically important to improve clinical outcomes. NPJ5008 will allow faster administration compared to the existing dantrolene formulation and therefore, we believe, better outcomes for all European patients with MH."

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Notes to Editors:

About Malignant Hyperthermia

Malignant hyperthermia (MH) is a rare life-threatening pharmacogenetic disorder of skeletal muscles that presents as an exaggerated hypermetabolic response to volatile anaesthetic agents and depolarizing muscle relaxants.^[1]

About NPJ5008

NPJ5008 is a novel formulation of dantrolene that has been developed by Norgine to shorten preparation and administration times versus DANTRIUM IV (dantrolene sodium). Each vial of NPJ5008 contains 120mg of dantrolene and is reconstituted in 20 mL of water for injections for intravenous administration.^[2]

About Norgine

Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people's lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enable us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped more than 25 million patients around the world in 2022 and generated ?530 million in net product sales, a growth of nearly 5% over 2021.

Norgine has a direct presence in 16 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

References:

1. Kaur et al. Mo Med. 2019;116(2):154?159.
2. Ng Kwet Shing RH, et al. Eur J Anaesthesiol. 2024;41:1?10.

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