PARI Pharma GmbH, a company focused on the development and commercialization of advanced aerosol delivery systems based on eFlow Technology, announces approval of its optimized eFlow technology nebulizer LAMIRA™ together with Insmed’s ARIKAYCE® (amikacin liposome inhalation suspension). The drug/device combination product received U.S. Food and Drug Administration (FDA) accelerated approval on September 28th, 2018 under a New Drug Application.
LAMIRA, designed, optimized, and developed by PARI Pharma, is intended only for use with ARIKAYCE and the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. ARIKAYCE is the first FDA approved inhaled liposomal suspension which is aerosolized using a vibrating membrane nebulizer. “LAMIRA is another great example of an eFlow Technology nebulizer which we optimized for the administration of a specific drug formulation, indicating the strong capabilities of the eFlow Technology platform,” states Dr. Martin Knoch, President of PARI Pharma. “It is rewarding to bring, in close collaboration with the team at Insmed, such technical advancements into the hands of patients with little to no alternative treatment options,” adds Dr. Knoch.
LAMIRA to deliver ARIKAYCE is PARI Pharma’s 3rd FDA approval where an eFlow Technology device was used exclusively to deliver the approved drug.
About MAC Lung Disease
Mycobacterium avium complex (MAC) lung disease is a rare and serious disorder that can significantly increase morbidity and mortality. Patients with MAC lung disease can experience a range of symptoms that often worsen over time, including chronic cough, dyspnea, fatigue, fever, weight loss, and chest pain. In some cases, MAC lung disease can cause severe, even permanent damage to the lungs, and can be fatal.
MAC lung disease is an emerging public health concern worldwide with significant unmet needs. Current guideline-based treatment involves the use of multi-drug regimens that are not specifically approved for MAC lung disease. The course of treatment is often two years or more and is inadequate in treating the disease in many patients.
About ARIKAYCE® (amikacin liposome inhalation suspension)
ARIKAYCE is the first and only FDA-approved therapy indicated for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed’s proprietary Pulmovance™ liposomal technology enables the delivery of amikacin directly to the lungs, where it is taken up by lung macrophages where the infection resides. This approach prolongs the release of amikacin in the lungs while limiting systemic exposure. ARIKAYCE is administered once daily using the LAMIRA Nebulizer System manufactured by PARI Pharma GmbH.