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Last Updated : Jan 08, 2019 01:00 PM IST | Source: Moneycontrol.com

Lupin gets EU nod for specialty drug to treat rare neuromuscular disorder

Lupin said it is preparing for the launch of NaMuscla in Germany and the UK in Q1 2019, while looking for partners to commercialise the drug in rest of the European territories.

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Lupin on Tuesday said the European Commission (EC) has approved specialty drug NaMuscla to treat a rare neuromuscular disorder.

NaMuscla, scientifically called as mexiletine is used for the symptomatic treatment of myotonia in adults with nondystrophic myotonic (NDM) disorders.

Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction.

Lupin said it is preparing for the launch of NaMuscla in Germany and the UK in Q1 2019, while looking for partners to commercialise the drug in rest of the European territories.

The EC approval follows the positive opinion which was issued by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), in October 2018 and will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein.

The approval makes NaMuscla which recently had its orphan drug designation ratified by the EMA’s Committee for Orphan Medicinal Products (COMP), the first treatment to be licensed throughout the EU for the symptomatic treatment of myotonia in adults with NDM disorders.

“We are delighted by the decision of the European Commission to approve NaMuscla, making it the first treatment to be licensed across the EU for patients with non-dystrophic myotonia,” said Thierry Volle, President EMEA, Lupin.

“The EC approval represents a further important milestone for Lupin as we build a leading specialty pharma company focused on the development, registration and commercialization of science-based therapies and solutions for areas of unmet medical need,” Volle said.

More than 7500 people in Europe are living with NDM have limited access to a licensed treatment for myotonia which reduces the daily burden of this disabling, lifelong symptom.

Lupin said it is also pursuing a paediatric investigation plan (PIP) for NaMuscla.

The approval was based on a pivotal Phase III clinical study (MYOMEX1) which enrolled 25 participants who were diagnosed with non-dystrophic myotonic disorders and symptomatic myotonia.

In randomized controlled trials, NaMuscla been shown to significantly reduce myotonia compared to placebo, reducing skeletal muscle hyperexcitability through its use-dependent, voltage-gated, sodium channel blocking actions which are independent of the cause of channel function. This resulted in an improvement in patient quality-of-life

Shares of Lupin rose 1.04 percent and were trading at Rs 829.40 on BSE at 12.20 pm, the benchmark Sensex gained 0.04 percent to 35,860.59 points.
First Published on Jan 8, 2019 01:00 pm
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