Amikacin liposomal inhaled - Insmed

Drug Profile

Amikacin liposomal inhaled - Insmed

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

Latest Information Update: 25 May 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 - Mycobacterial infections; Cystic fibrosis-associated respiratory tract infections
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 23 May 2018 Additional efficacy data from the phase III trial in Mycobacterial infections released by Insmed
  • 16 May 2018 FDA assigns PDUFA action date of 28/09/2018 for Amikacin liposomal inhaled for Mycobacterial infections (Adjunctive treatment, Treatment-resistant)
  • 16 May 2018 US FDA grants Priority Review status for and NDA for Amikacin liposomal inhaled for Mycobacterial infections (Adjunctive treatment, Treatment-resistant)
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