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Amikacin liposomal inhaled - Insmed

Drug Profile

Amikacin liposomal inhaled - Insmed

Alternative Names: ALIS; Amikacin Liposome Inhalation Suspension; Arikace; ARIKAYCE; Liposomal amikacin for inhalation; SLIT™ Amikacin

Latest Information Update: 20 Dec 2018

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At a glance

  • Originator Transave
  • Developer Insmed; National Institute of Allergy and Infectious Diseases; Oregon Health & Science University; University of Texas Health Science Center at Tyler
  • Class Aminoglycosides; Antibacterials; Small molecules
  • Mechanism of Action Protein 30S ribosomal subunit inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Cystic fibrosis-associated respiratory tract infections; Mycobacterial infections
  • New Molecular Entity No

Highest Development Phases

  • Marketed Mycobacterial infections
  • Preregistration Cystic fibrosis-associated respiratory tract infections
  • Phase II Bronchiectasis

Most Recent Events

  • 04 Jan 2019 Insmed intends to complete the design and protocol of the confirmatory clinical study during the first half of 2019 required for the full approval of amikacin liposome inhalation suspension by the US FDA in a front-line setting of patients with Mycobacterial infections
  • 04 Jan 2019 Insmed intends to file regulatory application for amikacin liposome inhalation suspension in Europe in mid-2019
  • 04 Jan 2019 Insmed plans to file a regulatory application with the Pharmaceuticals and Medical Device Agency for approval of Amikacin liposomal inhaled in in the first half of 2020
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