Lyfnua

Authorised

This medicine is authorised for use in the European Union

gefapixant

Overview

Lyfnua is a medicine used to treat adults with chronic (long-term) cough which is unexplained or for which other treatments have not worked.

The medicine contains the active substance gefapixant.

How is Lyfnua used?

In response to inflammation or airway irritation, cells within the lining of the airways produce high levels of a substance called ATP. ATP attaches to specific receptors (targets) on nerve cells in the airways, which stimulates the nerves and triggers the urge to cough. The active substance in Lyfnua, gefapixant, blocks these receptors and keeps the nerves from triggering the cough reflex.

What benefits of Lyfnua have been shown in studies?

The benefits of Lyfnua were investigated in two main studies involving 1,360 adults with chronic cough, who were given Lyfnua or placebo (a dummy treatment). Lyfnua was shown to be more effective than placebo at lowering the average number of times patients coughed per hour, measured over a 24-hour period. In the first study, after 12 weeks of treatment, the average number of coughs per hour in patients given Lyfnua went from 18.2 to 7.1 (a reduction of 61%) compared with a decrease from 22.8 to 10.3 (a reduction of 55%) in patients given placebo. In the second study, after 24 weeks of treatment, the average number of coughs per hour went from 18.6 to 6.8 (a reduction of 63%) in patients given Lyfnua compared with a decrease from 19.5 to 8.3 (a reduction of 57%) in patients given placebo.

What are the risks associated with Lyfnua?

For the full list of side effects and restrictions with Lyfnua, see the package leaflet.

The most common side effects with Lyfnua (which may affect more than 1 in 10 people) include taste disorders: dysgeusia (changes in the sense of taste), ageusia (loss of sense of taste) and hypogeusia (reduced sense of taste).

Why is Lyfnua authorised in the EU?

Lyfnua showed a modest effect in terms of reducing the number of daily coughs in patients with chronic cough. Side effects with Lyfnua are considered manageable; the most common side effects concerned taste disorders and these generally resolved once patients stopped treatment. The European Medicines Agency therefore decided that Lyfnua’s benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Lyfnua?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lyfnua have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Lyfnua are continuously monitored. Suspected side effects reported with Lyfnua are carefully evaluated and any necessary action taken to protect patients.

Other information about Lyfnua

Lyfnua received a marketing authorisation valid throughout the EU on 15 September 2023.

Lyfnua - EPAR - Medicine overview

Reference Number: EMA/342744/2023

Lyfnua : EPAR - Risk management plan

Product information

Lyfnua : EPAR - Product information

Lyfnua : EPAR - All authorised presentations

Product details

• Name of medicine:
  Lyfnua
• Active substance:
  Gefapixant
• International non-proprietary name (INN) or common name:
  gefapixant
• Therapeutic area (MeSH):
  Cough
• Anatomical therapeutic chemical (ATC) code:
  R05DB29

Pharmacotherapeutic group

Cough and cold preparations

Therapeutic indication

Lyfnua is indicated in adults for the treatment of refractory or unexplained chronic cough.

Authorisation details

• EMA product number:
  EMEA/H/C/005476
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.

  Waarderweg 39; 2031 BN Haarlem; The Netherlands

• Opinion adopted:
  20/07/2023
• Marketing authorisation issued:
  15/09/2023
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

Lyfnua : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Lyfnua : EPAR - Public assessment report

AdoptedReference Number: EMA/357321/2023 Corr.1

CHMP summary of positive opinion for Lyfnua

AdoptedReference Number: EMA/CHMP/322106/2023