Icatibant Accord

Authorised

This medicine is authorised for use in the European Union

icatibant

Overview

Icatibant Accord is a medicine used to treat the symptoms of hereditary angioedema in patients aged 2 years and over.

Patients with angioedema have rapid swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain. Attacks of hereditary angioedema can be life threatening when the swelling around the throat presses against the airway. Icatibant Accord is used in patients whose angioedema is linked to naturally low levels of a protein called ‘C1 esterase inhibitor’.

Icatibant Accord contains the active substance icatibant and is a ‘generic medicine’. This means that Icatibant Accord contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Firazyr.

How is Icatibant Accord used?

Treatment with Icatibant Accord should be started under the supervision of a healthcare professional. Icatibant Accord is available as a solution in a pre-filled syringe to be injected slowly under the skin, preferably in the abdomen (belly). The doctor may decide that the patient or their caregiver can inject the medicine themselves, after they have been trained by a healthcare professional.

The recommended dose of Icatibant Accord in adults is one single injection. If symptoms continue or come back, a second injection can be given after 6 hours. If needed, treatment can be repeated for a third time after an additional 6 hours. No more than three injections should be given in any 24-hour period. The dose for adolescents and children depends on their body weight.

The medicine can only be obtained with a prescription.

For more information about using Icatibant Accord, see the package leaflet or contact your doctor or pharmacist.

How does Icatibant Accord work?

Patients with hereditary angioedema have high levels of a substance called ‘bradykinin’, which is involved in causing inflammation and swelling. The active substance in Icatibant Accord, icatibant, blocks the receptors that bradykinin normally attaches to. This blocks the activity of bradykinin, helping to relieve the symptoms of the disease.

How has Icatibant Accord been studied?

Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Firazyr, and do not need to be repeated for Icatibant Accord.

As for every medicine, the company provided data on the quality of Icatibant Accord. There was no need for ‘bioequivalence’ studies to investigate whether Icatibant Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because the composition of Icatibant Accord is very similar to the reference medicine and when given by injection under the skin, the active substance in both products is expected to be absorbed in the same way.

What are the benefits and risks of Icatibant Accord?

Because Icatibant Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Why is Icatibant Accord authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Icatibant Accord has been shown to be comparable to Firazyr. Therefore, the Agency’s view was that, as for Firazyr, the benefits of Icatibant Accord outweigh the identified risks and it can be authorised for use in the EU.

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

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

Other information about Icatibant Accord

Icatibant Accord received a marketing authorisation valid throughout the EU on 16 July 2021.

Icatibant Accord : EPAR - Medicine overview

Reference Number: EMA/308584/2021

Icatibant Accord : EPAR - Risk-management-plan summary

Product information

Icatibant Accord : EPAR - Product information

Latest procedure affecting product information: N/0001

25/01/2024

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Icatibant Accord : EPAR - All authorised presentations

Product details

• Name of medicine:
  Icatibant Accord
• Active substance:
  icatibant acetate
• International non-proprietary name (INN) or common name:
  icatibant
• Therapeutic area (MeSH):
  Angioedemas, Hereditary
• Anatomical therapeutic chemical (ATC) code:
  B06AC02

Pharmacotherapeutic group

Other hematological agents

Therapeutic indication

Icatibant Accord is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older, with C1 esterase inhibitor deficiency.

Authorisation details

• EMA product number:
  EMEA/H/C/005083
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Accord Healthcare S.L.U.

  Edificio Este Planta 6a; World Trade Center; Moll De Barcelona S/n; 08039 Barcelona; SPAIN

• Opinion adopted:
  20/05/2021
• Marketing authorisation issued:
  16/07/2021
• Revision:
  1

Assessment history

Changes since initial authorisation of medicine

Icatibant Accord : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Icatibant Accord : EPAR - Public assessment report

AdoptedReference Number: EMA/306744/2021

CHMP summary of positive opinion for Icatibant Accord

AdoptedReference Number: EMA/CHMP/244588/2021