Kovaltry

octocog alfa

  • Email
  • Help

About

This is a summary of the European public assessment report (EPAR) for Kovaltry. 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 Kovaltry.

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

What is Kovaltry and what is it used for?

Kovaltry is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of a clotting protein called factor VIII). It contains the active substance octocog alfa, which is the same as human factor VIII.

How is Kovaltry used?

Kovaltry 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 Kovaltry 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.

Kovaltry can only be obtained with a prescription and treatment should be 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 Kovaltry work?

Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems such as bleeding into the joints, muscles and internal organs. The active substance in Kovaltry, octocog 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 Kovaltry have been shown in studies?

The effectiveness of Kovaltry in preventing and treating bleeding has been shown in a main study involving 62 patients aged 12 years or older with severe haemophilia A who were previously treated with other factor VIII products. The number of bleeds that occurred during Kovaltry treatment was calculated as 3.8 bleeds per year on average (mostly into joints). This compared with an average of 6.9 bleeds per year before Kovaltry treatment. Comparable results were seen in patients who continued to take the medicine after completion of the initial study.

About 70% of the bleeding events that occurred were managed with a single injection of Kovaltry, and about another 15% responded to a second injection; the response was considered good or excellent in around 80% of cases. In 12 patients who required major surgery during the study, control of blood loss was also rated as good or excellent by the patients’ doctors.

A second study involved 51 children under 12 years of age previously treated with other factor VIII products, who also had 3.8 bleeds per year on average during treatment with Kovaltry (mostly related to injuries). Response to treatment was considered good or excellent in about 90% of cases.

Data from a supportive study also confirmed the benefits of preventative treatment with Kovaltry in reducing the number of bleeds.

What are the risks associated with Kovaltry?

Hypersensitivity (allergic) reactions are uncommon with Kovaltry, affecting from 1 patient in 1,000 to less than 1 patient in 100. If they occur they may include: angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash over the whole body, headache, hives, hypotension (low blood pressure), lethargy, nausea (feeling sick), restlessness, tachycardia (rapid heartbeat), tightness of the chest, tingling, vomiting and wheezing. In some cases these reactions can become severe.

Patients may develop antibodies to hamster or mouse proteins; the medicine must not be used in patients who are hypersensitive (allergic) to octocog alfa or to hamster or mouse proteins. 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 Kovaltry, see the package leaflet.

Why is Kovaltry approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Kovaltry’s benefits are greater than its risks and recommended that it be approved for use in the EU. Kovaltry has been shown to be effective in both preventing and treating bleeds, including managing blood loss during surgery, and can be used in all age groups. Regarding safety, the reported effects are in line with those expected for a factor VIII product. Further evidence of effectiveness and safety in patients previously untreated with factor VIII medicines, and further data on long-term use in children should be provided by ongoing studies.

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

A risk management plan has been developed to ensure that Kovaltry 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 Kovaltry, 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.

In addition, the company that markets Kovaltry will complete studies to investigate the safety and efficacy of the medicine in patients who have not previously been treated with other factor VIII products, and to provide further evidence of the safety and efficacy of long-term treatment with Kovaltry in children.

Other information about Kovaltry

The European Commission granted a marketing authorisation valid throughout the European Union for Kovaltry on 18 February 2016.

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

Name Language First published Last updated
Kovaltry : EPAR - Summary for the public BG = bălgarski 2016-03-07  
Kovaltry : EPAR - Summary for the public ES = español 2016-03-07  
Kovaltry : EPAR - Summary for the public CS = čeština 2016-03-07  
Kovaltry : EPAR - Summary for the public DA = dansk 2016-03-07  
Kovaltry : EPAR - Summary for the public DE = Deutsch 2016-03-07  
Kovaltry : EPAR - Summary for the public ET = eesti keel 2016-03-07  
Kovaltry : EPAR - Summary for the public EL = elliniká 2016-03-07  
Kovaltry : EPAR - Summary for the public EN = English 2016-03-07  
Kovaltry : EPAR - Summary for the public FR = français 2016-03-07  
Kovaltry : EPAR - Summary for the public IT = italiano 2016-03-07  
Kovaltry : EPAR - Summary for the public LV = latviešu valoda 2016-03-07  
Kovaltry : EPAR - Summary for the public LT = lietuvių kalba 2016-03-07  
Kovaltry : EPAR - Summary for the public HU = magyar 2016-03-07  
Kovaltry : EPAR - Summary for the public MT = Malti 2016-03-07  
Kovaltry : EPAR - Summary for the public NL = Nederlands 2016-03-07  
Kovaltry : EPAR - Summary for the public PL = polski 2016-03-07  
Kovaltry : EPAR - Summary for the public PT = português 2016-03-07  
Kovaltry : EPAR - Summary for the public RO = română 2016-03-07  
Kovaltry : EPAR - Summary for the public SK = slovenčina 2016-03-07  
Kovaltry : EPAR - Summary for the public SL = slovenščina 2016-03-07  
Kovaltry : EPAR - Summary for the public FI = suomi 2016-03-07  
Kovaltry : EPAR - Summary for the public SV = svenska 2016-03-07  
Kovaltry : EPAR - Summary for the public HR = Hrvatski 2016-03-07  
Name Language First published Last updated
Kovaltry : EPAR - Risk-management-plan summary (English only) 2016-03-07  

This EPAR was last updated on 29/11/2016 .

Authorisation details

Product details

Product details for Kovaltry
NameKovaltry
Agency product numberEMEA/H/C/003825
Active substance

octocog alfa

International non-proprietary name (INN) or common name

octocog 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 Kovaltry
Marketing-authorisation holder

Bayer Pharma AG

Revision2
Date of issue of marketing authorisation valid throughout the European Union18/02/2016

Contact address:

Bayer Pharma AG 
Muellerstrasse 178 
13353 Berlin 
Germany

Product information

Product information

20/07/2016  Kovaltry -EMEA/H/C/003825 -IB/0002/G

Name Language First published Last updated
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - Product Information EN = English 2016-03-07 2016-11-29

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
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29
Kovaltry : EPAR - All Authorised presentations EN = English 2016-03-07 2016-11-29

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Kovaltry : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2016-08-02 2016-11-29

Initial marketing-authorisation documents

Name Language First published Last updated
Kovaltry : EPAR - Public assessment report EN = English 2016-03-07 2016-03-09
CHMP summary of opinion for Kovaltry EN = English 2015-12-18  

Authorised

This medicine is approved for use in the European Union

Patient safety


Related information