Inhixa

Summary

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/510445/2016

EMEA/H/C/004264

EPAR summary for the public

Inhixa

Enoxaparin sodium

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

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

What is Inhixa and what is it used for?

Inhixa is an anticoagulant medicine (a medicine to prevent blood clots). It is used in adults for the

following:

• to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they are bedridden due to illness;

• to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg);

• to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);

• to treat certain types of myocardial infarction (heart attack);

• to prevent clots forming when blood is circulated through a haemodialysis machine to remove toxic substances.

In the treatment of unstable angina and heart attack Inhixa is given with aspirin (acetylsalicylic acid).

The active substance in Inhixa is enoxaparin sodium.

An agency of the European Union

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

Inhixa is a 'biosimilar medicine'. This means that Inhixa is highly similar to a biological medicine (also known as the 'reference medicine') that is already authorised in the European Union (EU). The reference medicine for Inhixa is Clexane. For more information on biosimilar medicines, see the question-and-answer document here.

How is Inhixa used?

Inhixa is available as a solution for injection in pre-filled syringes. It is usually given as an injection under the skin although in the treatment of a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI) it is first given as an injection into a vein, and to prevent clots in haemodialysis machines it is injected directly into the tube carrying the blood. The dose and how long the medicine is given for, as well as whether it is given with other medicines, depend on the condition to be prevented or treated. Doses must be adjusted in patients with severely reduced kidney function.

The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does Inhixa work?

When blood clots develop inside blood vessels they may restrict the blood flow to the organs, including the heart. The active substance in Inhixa, enoxaparin, is one of a group of anticoagulant medicines called 'low-molecular weight heparins'. Enoxaparin increases the effect of antithrombin III, a natural substance that controls the blood's clotting factors and helps prevent blood from clotting inside the body. This helps to stop the formation of new blood clots and control existing ones.

What benefits of Inhixa have been shown in studies?

Extensive laboratory studies comparing Inhixa with Clexane have shown that Inhixa is highly similar to Clexane in terms of structure, purity and biological activity.

In addition, a study in 20 healthy subjects has shown the same doses of the two products given by injection under the skin produced similar effects on blood clotting factors, using various measures that reflect the way the medicine works in the body.

The company also provided information from published studies showing the benefits of enoxaparin in preventing and treating blood clots.

What are the risks associated with Inhixa?

The most common side effect with Inhixa (which may affect more than 1 in 10 people) is haemorrhage (bleeding); serious bleeding occurred in around 4 people in 100 given Inhixa to prevent blood clots during surgery. In addition, increased levels of liver enzymes in the blood (a sign of possible liver problems) are very common (may affect more than 1 in 10 people).

For the full list of all side effects reported with Inhixa, see the package leaflet.

Inhixa must not be used in patients with existing major bleeding, severe disorders of blood clotting, or with conditions that increase the risk of, or from, bleeding, such as stomach ulcers or stroke. For the full list of restrictions, see the package leaflet.

Why is Inhixa approved?

Studies have shown that Inhixa has a highly similar structure and biological activity to Clexane and has the same effect on blood clotting factors. The safety profiles of the two medicines were also considered similar, based on laboratory testing.

Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Inhixa and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk. The Committee recommended that Inhixa be given marketing authorisation.

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

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

Other information about Inhixa

The European Commission granted a marketing authorisation valid throughout the European Union for Inhixa on 15 September 2016.

The full EPAR for Inhixa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Inhixa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 10-2016.

Page 3/3

Inhixa

EMA/510445/2016