Arikayce liposomal

amikacin

Table of contents

Opinion

On 23 July 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Arikayce liposomal,1 intended for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis. The applicant for this medicinal product is Insmed Netherlands B.V.

Arikayce liposomal will be available as a 590-mg nebuliser dispersion2. The active substance of Arikayce liposomal is amikacin, a well-established aminoglycoside antibacterial (ATC code: J01GB06), the mode of action of which is disruption of production of vital bacterial proteins.

The benefits with Arikayce liposomal are its ability to treat the above-mentioned infections effectively. The most common side effects are nephrotoxicity, ototoxicity and effects on neuromuscular conditions that may be due to chronic exposure to amikacin.

The full indication is:

Arikayce liposomal is indicated for the treatment of non-tuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium Complex (MAC) in adults with limited treatment options who do not have cystic fibrosis (see sections 4.2, 4.4 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1 This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

2 Correction from suspension to dispersion

Key facts

Name
Arikayce liposomal
Agency product number
EMEA/H/C/005264
International non-proprietary name (INN) or common name
  • amikacin
Active substance
  • Amikacin sulfate
Therapeutic area
Respiratory Tract Infections
Date opinion adopted
23/07/2020
Company name
Insmed Netherlands B.V.
Status
Positive
Application type
Initial authorisation

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