Enables expanded access to the only EU-approved treatment for myotonia symptoms in adults with non-dystrophic myotonic disorders

Lupin and Avas Pharmaceuticals announced the launch of Lupin’s orphan drug NaMuscla (mexiletine) in Italy. Avas will commercialise NaMuscla for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. NaMuscla is the first and only licensed product for this indication.

NDM disorders are a group of rare, inherited neuromuscular disorders which is characterised by the inability to relax muscles following voluntary contraction. NaMuscla reduces myotonia symptoms in people with NDM, resulting in a significant improvement in quality of life and other functional and clinical outcomes for patients1. NaMuscla, which has been designated orphan drug status, received EU marketing authorisation in December 2018.

Under the terms of the agreement, Avas will initially commercialise NaMuscla as a Class C (Tier 2), while Lupin negotiates with AIFA (Agenzia Italiana del Farmaco) for the reimbursement of the product in Italy. This will ensure consistent access to NaMuscla for patients in Italy, leveraging the established supply network that already serves patients across Germany, France, Spain, Austria, Norway, Sweden and the UK.

“Our collaboration with Avas will not only allow us to introduce the first licensed treatment for myotonia in Italy but also ensure continued access to this essential medication. This partnership reflects Lupin’s dedication to addressing unmet medical needs in rare diseases across Europe,” stated Thierry Volle, President EMEA, Lupin.

“We are excited to announce our partnership with Lupin for the launch of NaMuscla in Italy, a key step in addressing the needs of patients with NDM disorders. This collaboration ensures the availability of best therapeutic solutions, improving the quality of life for individuals affected by NDM disorders in Italy," said Marco Rago, President of the Board of Directors, Avas Pharmaceuticals.