PARI Pharma, a German manufacturer of aerosol delivery products, won FDA approval of its LAMIRA nebulizer along with Insmed‘s ARIKAYCE (amikacin liposome inhalation suspension) drug for treating lung infections caused by the mycobacterium avium complex (MAC), a group of bacteria that are difficult to treat in many patients.
The approval of the drug is the first under the FDA’s new Limited Population Pathway for Antibacterial and Antifungal Drugs, which helps to speed up approvals for certain medications.
The LAMIRA device is specifically designed to be used with ARIKAYCE to treat MAC lung disease in patients that didn’t respond to conventional antibiotic therapy. Inside the LAMIRA is a vibrating membrane nebulizer that aerosolizes the liposomal suspension of ARIKAYCE, a technology PARI calls “eFlow”. It allows designers of nebulizers to optimize them for specific drugs, as to achieve the best penetration and clinical efficacy.
Via: PARI Pharma…