Obizur

susoctocog alfa

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

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

What is Obizur and what is it used for?

Obizur is a medicine used for the treatment of bleeding episodes in adults with acquired haemophilia, a bleeding disorder caused by the spontaneous development of antibodies that inactivate factor VIII. Factor VIII is one of the proteins needed for normal clotting of the blood.

Obizur contains the active substance susoctocog alfa.

How is Obizur used?

Obizur can only be obtained with a prescription and treatment should be supervised by a doctor with experience in the treatment of haemophilia. Obizur is available as a powder and solvent that are mixed together to make a solution for injection into a vein. The dose, and how often it is given, as well as the length of treatment, are adjusted depending on the patient’s condition and requirements, and the degree of danger posed by the bleeding. For further information, see the summary of product characteristics (also part of the EPAR).

How does Obizur work?

Patients with acquired haemophilia caused by antibodies against factor VIII have blood clotting problems, such as bleeding in the joints, muscles or internal organs. The active substance in Obizur, susoctocog alfa, works in the body in the same way as human factor VIII, but has a slightly different shape. As a result, it will not be as easily recognised by the antibodies and it can replace the human factor VIII that has been inactivated, thereby helping the blood to clot and controlling the bleeding.

What benefits of Obizur have been shown in studies?

Obizur has been investigated in one main study involving 28 adult patients with acquired haemophilia caused by antibodies against factor VIII who were experiencing a serious bleeding episode. Obizur was not compared with any other medicine. The response to Obizur was considered positive if bleeding stopped or was reduced, while a negative response meant that the bleeding continued or worsened. All 28 patients showed a positive response within 24 hours of starting treatment with Obizur; in 24 out of 28 patients, the bleeding stopped completely.

What are the risks associated with Obizur?

Hypersensitivity (allergic) reactions may occur with Obizur, and can include angioedema (swelling of tissues under the skin), burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, hypotension (low blood pressure), feeling tired or restless, nausea (feeling sick) or vomiting, tachycardia (rapid heartbeat), tightness of the chest, wheezing and tingling sensations. In some cases, reactions become severe (anaphylaxis) and may be associated with dangerously steep falls in blood pressure. Obizur must not be used in patients who have had a severe allergic reaction to susoctocog alfa, any of its other ingredients, or hamster protein. Patients with acquired haemophilia caused by antibodies against factor VIII may develop antibodies against susoctocog alfa.

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

Why is Obizur approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Obizur are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted the lack of specific treatments for acquired haemophilia caused by antibodies against factor VIII. The results of the main study showed that Obizur was effective in treating serious bleeding episodes in adults with the disorder. With regard to safety, the Committee considered that the potential for allergic reactions and the development of antibodies against the medicine is expected, and is outweighed by the beneficial effects.

Obizur has been authorised under ‘exceptional circumstances’. This is because it has not been possible to obtain complete information about Obizur due to the rarity of the disease. Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.

What information is still awaited for Obizur?

Since Obizur has been approved under exceptional circumstances, the company that markets the medicine will establish and maintain a patient registry to collect and analyse short- and long-term data on the effectiveness and safety of Obizur in patients with acquired haemophilia caused by antibodies against factor VIII.

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

A risk management plan has been developed to ensure that Obizur 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 Obizur, including the appropriate precautions to be followed by healthcare professionals and patients.

Additionally, the company that markets Obizur will provide healthcare professionals who are expected to use Obizur with educational material containing information on how to calculate the dose.

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

Other information about Obizur

The European Commission granted a marketing authorisation valid throughout the European Union for Obizur on 11 November 2015.

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

Name Language First published Last updated
Obizur : EPAR - Summary for the public BG = bălgarski 23/11/2015  
Obizur : EPAR - Summary for the public ES = español 23/11/2015  
Obizur : EPAR - Summary for the public CS = čeština 23/11/2015  
Obizur : EPAR - Summary for the public DA = dansk 23/11/2015  
Obizur : EPAR - Summary for the public DE = Deutsch 23/11/2015  
Obizur : EPAR - Summary for the public ET = eesti keel 23/11/2015  
Obizur : EPAR - Summary for the public EL = elliniká 23/11/2015  
Obizur : EPAR - Summary for the public EN = English 23/11/2015  
Obizur : EPAR - Summary for the public FR = français 23/11/2015  
Obizur : EPAR - Summary for the public IT = italiano 23/11/2015  
Obizur : EPAR - Summary for the public LV = latviešu valoda 23/11/2015  
Obizur : EPAR - Summary for the public LT = lietuvių kalba 23/11/2015  
Obizur : EPAR - Summary for the public HU = magyar 23/11/2015  
Obizur : EPAR - Summary for the public MT = Malti 23/11/2015  
Obizur : EPAR - Summary for the public NL = Nederlands 23/11/2015  
Obizur : EPAR - Summary for the public PL = polski 23/11/2015  
Obizur : EPAR - Summary for the public PT = português 23/11/2015  
Obizur : EPAR - Summary for the public RO = română 23/11/2015  
Obizur : EPAR - Summary for the public SK = slovenčina 23/11/2015  
Obizur : EPAR - Summary for the public SL = slovenščina 23/11/2015  
Obizur : EPAR - Summary for the public FI = suomi 23/11/2015  
Obizur : EPAR - Summary for the public SV = svenska 23/11/2015  
Obizur : EPAR - Summary for the public HR = Hrvatski 23/11/2015  
Name Language First published Last updated
Obizur : EPAR - Risk-management-plan summary (English only) 23/11/2015  

This EPAR was last updated on 17/05/2016 .

Authorisation details

Product details

Product details for Obizur
NameObizur
Agency product numberEMEA/H/C/002792
Active substance

susoctocog alfa

International non-proprietary name (INN) or common name

susoctocog alfa

Therapeutic area Hemophilia A
Anatomical therapeutic chemical (ATC) code B02
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.

Exceptional Circumstances

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Obizur
Marketing-authorisation holder

Baxalta Innovations GmbH

Revision1
Date of issue of marketing authorisation valid throughout the European Union11/11/2015

Contact address:

Baxalta Innovations GmbH
Industriestrasse 67
A-1221 Vienna
Austria

Product information

Product information

21/04/2016  Obizur -EMEA/H/C/002792 -IA/0001/G

Name Language First published Last updated
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016
Obizur : EPAR - Product Information EN = English 23/11/2015 17/05/2016

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
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  
Obizur : EPAR - All Authorised presentations EN = English 23/11/2015  

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII. Obizur is indicated in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Obizur : EPAR - Procedural steps taken and scientific information after authorisation EN = English 17/05/2016  

Initial marketing-authorisation documents

Name Language First published Last updated
Obizur : EPAR - Public assessment report EN = English 23/11/2015  
CHMP summary of positive opinion for Obizur EN = English 24/07/2015  

Authorised

This medicine is approved for use in the European Union

Patient safety


Related information

More information on Obizur

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, Obizur has now been removed from the Community register of orphan medicinal products.

Preventing medication errors