Since 2010, six inhaled medicinal products which are administered via eFlow® Technology nebulizers have been approved by regulatory authorities whether in the US, Europe, Canada or Japan. PARI contributed to such filings with its expertise in medical device regulatory affairs. Following PARI’s tradition, eFlow Technology nebulizers are manufactured according to the highest quality standards. Frequent and recurrent quality system audits by our pharma partners confirm this year after year.
Commercial products:
PARI´s track record – drug products approved with an eFlow Technology nebulizer in the US, EU, Canada or Japan (please note the approval for each drug)
The Lamira Nebulizer System is specifically optimized for the administration of Insmed’s ARIKAYCE. Insmed is a global biopharmaceutical company headquartered in the USA.
ARIKAYCE (amikacin liposome inhalation suspension) was approved in the USA in 2018 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. It is the only FDA-approved treatment for this patient population.
This was followed by the approval of ARIKAYCE Liposomal 590 mg Nebuliser Dispersion in the EU in October 2020. It’s the first inhaled liposomal dispersion approved by the European Commission and the first and only therapy in the European Union indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by MAC in adults with limited treatment options who do not have cystic fibrosis.
In 2021, approval was also granted in Japan. The Lamira Nebulizer System has been authorized as a medical device by submitting the manufacturing and marketing notification to be used for the delivery of ARIKAYCE (amikacin liposomal inhalation suspension), which has been separately approved by Japan’s Ministry of Health, Labour and Welfare (MHLW). Thus, ARIKAYCE is the first and only therapy in Japan indicated for the treatment of patients with non-tuberculous mycobacterial (NTM) lung disease who did not sufficiently respond to prior treatment with a multidrug regimen. The Lamira Nebulizer System in Japan is also approved for reimbursement by the Central Social Insurance Medical Council (Chuikyo).
ARIKAYCE has been associated with an increased risk of respiratory adverse reactions, including hypersensitivity pneumonitis, hemoptysis, bronchospasm, and exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases. For more information including boxed warning please visit www.arikayce.com
Further information:
LONHALA MAGNAIR is the first nebulized long-acting muscarinic antagonist (LAMA) approved for the treatment of COPD in the U.S. and the first use of the MAGNAIR, which is based on the closed eFlow® Technology nebulizer, developed by PARI Pharma GmbH, to treat COPD. This technology is a virtually silent, portable, closed system nebulizer that is designed to deliver the drug in two to three minutes and allows people to breathe normally while using the device.
Further information:
Get a detailed look at the device features of LONHALA MAGNAIR.
Learn about the evolution of nebulizer technology leading up to the MAGNAIR Nebulizer System.
Watch excerpts from an instructional video on how to set-up, administer, and clean LONHALA MAGNAIR, which is included in the US approved prescription packaging.
San Diego based Mpex Pharmaceuticals Inc. initiated the development of inhaled levofloxacin for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis. Raptor Pharmaceuticals Inc. valued QUINSAIR with an upfront payment of $68 million, up to $34 million Raptor shares as well as contingent payments of up to $350 million. Inhaled levofloxacin has been sold under the brand name QUINSAIR in Europe and Canada since 2016 and is administered via an eFlow® Technology nebulizer called Zirela.
Further information:
Vantobra (tobramycin 170 mg) is a development and proprietary drug product of PARI Pharma. It is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF). Vantobra is administered via an eFlow® nebulizer handset called Tolero and distributed in some EU countries by PARI owned subsidiaries or selected distribution partners.
Further information:
ColiFin / Colfinair (colistimethate sodium for nebulization) is a product of PARI Pharma. It may be used for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adults and children with cystic fibrosis. The medicinal product is administered via an eFlow®rapid nebulizer handset. ColiFin / Colfinair provides the patient with the saline solution for reconstitution and a new nebulizer handset with each package. This specific drug and device concept is marketed in several countries in the EU and is highly accepted, providing a unique selling proposition in the treatment of chronic pulmonary infections.
Further information:
ARIKAYCE is a registered trademark of Insmed Incorporated
Cayston® is a registered trademark of Gilead Sciences Inc.
Lonhala® is a registered trademark of Sunovion Pharmaceuticals Inc.
SUNOVION is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.
QUINSAIR™ is a trademark of Horizon
eFlow®, eBase®, eLete®, eTrack®, ePort®, eRapid®, Altera®, Zirela®, Tolero®, Magnair®, Lamira®, Vantobra®, ColiFin®, Colfinair® and Vibrent® are registered trademarks of PARI Pharma GmbH
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