Lupin Launches Orphan Drug NaMuscla® in Germany and the UK for the Treatment of Myotonia in Non-Dystrophic Myotonic Disorders

Deepthi | Myequity news | Date : 01-02-2019 18:30:00 IST

Lupin launched NaMuscla® (mexiletine) in Germany and the United Kingdom (UK). NaMuscla® is approved across the European Union (EU) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. These disorders are a group of rare, inherited neuromuscular conditions in which myotonia, the inability to relax muscles following voluntary contraction, is the most prominent clinical symptom. NaMuscla® reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality- of-life and other functional outcomes.

The launch of NaMuscla® in Germany and the UK follows the European Commission’s approval of the product on 18 December 2018. NaMuscla®, designated an Orphan Drug by the European Medicines Agency (EMA), is the first treatment to be licensed across the EU for the symptomatic treatment of myotonia in adults with NDM disorders. The product will be commercialized in Germany by Hormosan Pharma GmbH, a full subsidiary of Lupin Ltd., and in the UK by Lupin Healthcare (UK) Ltd.

“We are delighted to be able to provide patient and market access to NaMuscla® in Germany and the UK,”
said Thierry Volle, President EMEA, Lupin. “NaMuscla® is the first licensed therapy for myotonia across the EU and offers an effective treatment option for patients living with this life-altering symptom. We look forward to additional launches for patients in other EU territories through 2019 and 2020.”

Lupin has ongoing partnering discussions for the commercialization of NaMuscla® in European territories outside of Germany and the UK.

Prior to the approval of NaMuscla®, the vast majority of more than 7500 people in Europe2,3,4 living with NDM had limited access to a licensed treatment for myotonia which reduced the daily burden of this life- altering symptom. Limited access leads to inconsistent medication supply, administrative challenges to both treating physicians and patients and associated financial burdens; this, along with low awareness and clinical experience among healthcare professionals, can result in harm to patients4. The EMA recognized the importance of having an effective therapy in adult NDM patients throughout the EU by granting NaMuscla® Orphan Drug status and the corresponding market exclusivity protection.

About Myotonic Disorders and Non-Dystrophic Myotonic (NDM) Disorders:

Myotonic disorders are a group of heterogeneous, inherited, neuromuscular disorders characterized by a shared symptom called myotonia. Myotonia can be described as an inability to relax a contraction of skeletal muscle which originates from a voluntary muscular contraction such as shaking someone’s hand and blinking, or everyday activities such as walking across a street and climbing stairs.

About Lupin Limited:

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

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