Amikacin liposomal inhaled - Insmed

Drug Profile

Amikacin liposomal inhaled - Insmed

Alternative Names: Amikacin sustained release; Arikace; ARIKAYCE; Liposomal amikacin for inhalation; SLIT™ Amikacin

Latest Information Update: 09 Nov 2016

Price : $50

At a glance

  • Originator Transave
  • Developer Insmed; National Institute of Allergy and Infectious Diseases
  • 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Mycobacterial infections
  • New Molecular Entity Yes

Highest Development Phases

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

Most Recent Events

  • 03 Nov 2016 Insmed completes enrolment in the CONVERT phase III trial for Mycobacterial infection in USA, Australia, Austria, France, Germany, New Zealand, Canada, Netherlands, Italy, Spain, United Kingdom, Japan and Poland
  • 18 Oct 2016 Adverse events and efficacy data from a phase II trial in Mycobacterial infection released by Insmed
  • 08 Jun 2016 Insmed withdraws MAA from the EMA for Mycobacterial infection
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