Elocta

efmoroctocog alfa

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This is a summary of the European public assessment report (EPAR) for Elocta. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Elocta.

For practical information about using Elocta, patients should read the package leaflet or contact their doctor or pharmacist.

What is Elocta and what is it used for?

Elocta is a medicine used to treat and prevent bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It contains the active substance efmoroctocog alfa.

How is Elocta used?

Elocta is available as a powder and solvent used to make a solution for injection. The injection is given into a vein over several minutes. The dose and frequency of the injections depend on whether Elocta is used to treat or prevent bleeding, the severity of the patient’s factor VIII deficiency, the extent and location of the bleeding and the patient’s condition and bodyweight.

Elocta can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia. For further information, see the summary of product characteristics (also part of the EPAR).

How does Elocta work?

Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily. The active substance in Elocta, efmoroctocog alfa, works in the body in the same way as human factor VIII. It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of bleeding.

What benefits of Elocta have been shown in studies?

Two main studies of Elocta showed that the medicine is effective at both preventing and treating bleeding episodes.

In a study of 165 adult patients with haemophilia A, patients who were given Elocta as a tailored preventive treatment had around 3 bleeding episodes a year, which compares with 37 episodes a year in patients not given preventive treatment. In addition, when bleeding did occur, Elocta treatment was rated as ‘excellent’ or ‘good’ in more than 78% of cases, with 87% of bleeding episodes resolving with only one injection.

In a study in 69 children, Elocta was similarly effective: 2 bleeding episodes occurred per year on average and 81% of bleeding episodes resolved with only one injection.

What are the risks associated with Elocta?

Hypersensitivity (allergic) reactions are seen rarely with Elocta and these include: swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the injection site, chills, flushing, itching over the whole body, headache, low blood pressure, lethargy, nausea, restlessness, and a fast heartbeat. In some cases these reactions can become severe.

There is also a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.

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

Why is Elocta approved?

Studies show that Elocta is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is in line with what is expected for medicines of its kind. The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore concluded that its benefits are greater than its risks and recommended that it be approved in the EU.

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

A risk management plan has been developed to ensure that Elocta is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Elocta, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Elocta

The European Commission granted a marketing authorisation valid throughout the European Union for Elocta on 19 November 2015.

For more information about treatment with Elocta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Elocta : EPAR - Summary for the public BG = bălgarski 2015-12-10  
Elocta : EPAR - Summary for the public ES = español 2015-12-10  
Elocta : EPAR - Summary for the public CS = čeština 2015-12-10  
Elocta : EPAR - Summary for the public DA = dansk 2015-12-10  
Elocta : EPAR - Summary for the public DE = Deutsch 2015-12-10  
Elocta : EPAR - Summary for the public ET = eesti keel 2015-12-10  
Elocta : EPAR - Summary for the public EL = elliniká 2015-12-10  
Elocta : EPAR - Summary for the public EN = English 2015-12-10  
Elocta : EPAR - Summary for the public FR = français 2015-12-10  
Elocta : EPAR - Summary for the public IT = italiano 2015-12-10  
Elocta : EPAR - Summary for the public LV = latviešu valoda 2015-12-10  
Elocta : EPAR - Summary for the public LT = lietuvių kalba 2015-12-10  
Elocta : EPAR - Summary for the public HU = magyar 2015-12-10  
Elocta : EPAR - Summary for the public MT = Malti 2015-12-10  
Elocta : EPAR - Summary for the public NL = Nederlands 2015-12-10  
Elocta : EPAR - Summary for the public PL = polski 2015-12-10  
Elocta : EPAR - Summary for the public PT = português 2015-12-10  
Elocta : EPAR - Summary for the public RO = română 2015-12-10  
Elocta : EPAR - Summary for the public SK = slovenčina 2015-12-10  
Elocta : EPAR - Summary for the public SL = slovenščina 2015-12-10  
Elocta : EPAR - Summary for the public FI = suomi 2015-12-10  
Elocta : EPAR - Summary for the public SV = svenska 2015-12-10  
Elocta : EPAR - Summary for the public HR = Hrvatski 2015-12-10  
Name Language First published Last updated
Elocta : EPAR - Risk-management-plan summary (English only) 2015-12-10  

This EPAR was last updated on 11/08/2016 .

Authorisation details

Product details

Product details for Elocta
NameElocta
Agency product numberEMEA/H/C/003964
Active substance

efmoroctocog alfa

International non-proprietary name (INN) or common name

efmoroctocog alfa

Therapeutic area Hemophilia A
Anatomical therapeutic chemical (ATC) code B02BD02
Additional monitoring

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

Publication details

Publication details for Elocta
Marketing-authorisation holder

Swedish Orphan Biovitrum AB (publ)

Revision2
Date of issue of marketing authorisation valid throughout the European Union19/11/2015

Contact address:

Swedish Orphan Biovitrum AB (publ)
SE-112 76
112 76 Stockholm
Sweden

Product information

Product information

05/07/2016  Elocta -EMEA/H/C/003964 -IB/0004/G

Name Language First published Last updated
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11
Elocta : EPAR - Product Information EN = English 2015-12-10 2016-08-11

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  
Elocta : EPAR - All Authorised presentations EN = English 2015-12-10  

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

Elocta can be used for all age groups.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Elocta : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-04-11 2016-08-11

Initial marketing-authorisation documents

Name Language First published Last updated
Elocta : EPAR - Public assessment report EN = English 2015-12-10  
CHMP summary of positive opinion for Elocta EN = English 2015-09-25  

Authorised

This medicine is approved for use in the European Union

Patient safety


More information on Elocta

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 20 September 2010. Upon request of the marketing-authorisation holder, Elocta has now been removed from the Community register of orphan medicinal products.