STARNBERG, Germany, March 24, 2021 / PRNewswire / – PARI Pharma GmbH, a company specializing in advanced aerosol delivery systems based on eFlow technology, announces the authorization of the LAMIRA nebulization system for the delivery of the drug product Insmed ARIKAYCE (suspension inhalation of amikacin liposomes) in Japan. Insmed obtained approval for ARIKAYCE by from Japan Ministry of Health, Labor and Welfare (MHLW) on March 23, 2021. The approval of ARIKAYCE in Japan follows earlier approvals in United States and Europe. LAMIRA is the first drug-specific eFlow Technology nebulizer registered beyond Europe and North America.
The LAMIRA nebulization system is specifically optimized for ARIKAYCE and therefore the only device intended to administer it. Key features of LAMIRA include a drug reservoir customized to hold a full 8.4ml dose, an aerosol head specially designed for the aerosolization of ARIKAYCE and the valve aerosol chamber.
ARIKAYCE is the first inhaled liposomal dispersion approved by the MHLW and the first and only therapy in Japan indicated for the treatment of patients with non-tuberculous mycobacterial lung disease (NTM) caused by Mycobacterium avium complex (CAM) that have not responded sufficiently to previous treatment with multidrug therapy.
“LAMIRA allows us to offer an eFlow Technology nebulizer to patients beyond Europe and North America. We are delighted that the appropriate patients in Japan suffering from NTM lung disease now have access to a new treatment option, ”said Dr. Martin knoch, Chairman of PARI Pharma.
Yuji orihara, General manager, Japan, for Insmed adds: “We are delighted that our valuable partnership with PARI has enabled us to bring to market the first approved drug, ARIKAYCE, to be used with the LAMIRA nebulizer specifically for the treatment of patients in Japan with refractory MAC lung disease. “
About PARI Pharma GmbH and eFlow Technology
PARI is a world leader in the development of aerosol delivery devices. PARI Pharma focuses on pharmaceutical licensing partnerships that use eFlow Technology nebulizers optimized for specific pharmaceuticals and formulations.
EFlow technology is an aerosol delivery platform that enables efficient nebulization of liquid drugs via a vibrating perforated membrane. EFlow Technology devices are designed to reduce the burden of treating patients with severe respiratory disorders.
ARIKAYCE is approved in United States like ARIKAYCE® (suspension for inhalation of amikacin liposomes), in the EU under the name ARIKAYCE® Liposomal dispersion 590 mg in nebulizer, and in Japan like ARIKAYCE® Inhalation 590 mg (amikacin sulfate drug product for inhalation). ARIKAYCE is a new formulation of amikacin inhaled once daily. Insmed’s proprietary PULMOVANCE ™ liposomal technology enables delivery of amikacin directly into the lungs. ARIKAYCE is administered once daily using exclusively the LAMIRA Nebulizer System.
IMPORTANT SAFETY INFORMATION FOR ARIKAYCE IN THE UNITED STATES
WARNING: RISK OF INCREASED RESPIRATORY SIDE EFFECTS
ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm and exacerbation of underlying lung disease which has led to hospitalizations in some cases.
SOURCE PARI Pharma