Lupin gets EU approval for own muscle disorder drug

Lupin said the European Commission (EC) has approved mexiletine for the symptomatic treatment of nondystrophic myotonic (NDM) disorders in adults.

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

Lupin’s NaMuscla reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional outcomes, the Indian pharmaceutical company said.

It said it is preparing for the launch of NaMuscla in Germany and the UK in the current quarter.

The company said it is conducting partnering discussions for the launch outside Germany and the UK.

Lupin said the drug was the first treatment to be licensed across the EU for patients with non-dystrophic myotonia.

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.

NaMuscla recently had its orphan drug designation ratified by the EMA’s Committee for Orphan Medicinal Products (COMP). Orphan drugs, meant for rare disorders, get special treatment in the approval process.

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

The company said that more than 7500 people in Europe living with NDM today have limited access to a licensed treatment for myotonia.

“Limited access leads to inconsistent medication supply, administrative challenges and associated financial burdens, which, along with low awareness and clinical experience among healthcare professionals, may result in harm to patients,” it said.

Lupin is also pursuing a paediatric investigation plan for NaMuscla.

“The approval and commercialization of NaMuscla brings to an end the difficult off-label treatment challenges faced by these patients,” Lupin said, quoting Professor Christiane Schneider-Gold of St. Josef und St. Elisabeth Hospital in Bochum, Germany.

“With no licensed antimyotonic drug being available to date, many patients have lived without treatment. NaMuscla fills an important, unmet clinical need for a licensed, efficacious treatment with a positive risk-benefit profile which is proven to significantly improve patient quality-of-life and disability caused by myotonia’s lifelong impact.”