MedPath
EMA Approval

Anagrelide Viatris (previously Anagrelide Mylan)

L01XX35

anagrelide

Antineoplastic agents

Basic Information

L01XX35

anagrelide

Antineoplastic agents

Therapeutic indication

Anagrelide Viatris is indicated for the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.

An at-risk patient

An at-risk essential thrombocythaemia patient is defined by one or more of the following features:

• >60 years of age or

• a platelet count >1,000 x 10⁹/l or

• a history of thrombo-haemorrhagic events.

Overview Summary

This is a summary of the European public assessment report (EPAR) for Anagrelide Viatris (previously Anagrelide Mylan). 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 Anagrelide Viatris.

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

Authorisations (1)

EMEA/H/C/004585

Viatris Limited,Damastown Industrial Park,Mulhuddart,Dublin 15,Ireland

Authorised

February 15, 2018

Active Substances (1)

anagrelide hydrochloride

Documents (12)

Anagrelide Viatris (previously Anagrelide Mylan) : EPAR - Procedural steps taken and scientific information after authorisation

April 25, 2019

CHANGES_SINCE_INITIAL_AUTHORISATION

Anagrelide Mylan : EPAR - Risk management plan summary

May 11, 2023

RISK_MANAGEMENT_PLAN_SUMMARY

Anagrelide Viatris : EPAR - Product Information

February 26, 2018

DRUG_PRODUCT_INFORMATION

Anagrelide Viatris (previously Anagrelide Mylan) : EPAR - Product Information

February 26, 2018

DRUG_PRODUCT_INFORMATION

Anagrelide Mylan : EPAR - Public assessment report

February 26, 2018

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Anagrelide Mylan : EPAR - Summary for the public

February 26, 2018

OVERVIEW_DOCUMENT

CHMP summary of positive opinion for Anagrelide Mylan

December 15, 2017

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Anagrelide Viatris (previously Anagrelide Mylan) : EPAR - All Authorised presentations

February 26, 2018

AUTHORISED_PRESENTATIONS

Anagrelide Viatris : EPAR - Procedural steps taken and scientific information after authorisation

March 3, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

Anagrelide Viatris (previously Anagrelide Mylan) : EPAR - Procedural steps taken and scientific information after authorisation (archive)

April 25, 2019

CHANGES_SINCE_INITIAL_AUTHORISATION

Anagrelide Mylan : EPAR - Public assessment report

February 26, 2018

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of positive opinion for Anagrelide Mylan

December 15, 2017

CHANGES_SINCE_INITIAL_AUTHORISATION

Overview Q&A (8)

Question

How is Anagrelide Mylan used?

Answer

Anagrelide Mylan can only be obtained with a prescription. Treatment should only be started by a doctor who has experience in treating essential thrombocythaemia.

Anagrelide Mylan is available as capsules (0.5 and 1 mg). The recommended starting dose is one

0.5 mg capsule twice a day. After a week, the dose is increased every week by 0.5 mg a day, until the platelet count is below 600 million platelets per millilitre, and ideally between 150 and 400 million/ml (the level usually seen in healthy people). Results are normally seen within 2 or 3 weeks of starting treatment.

The maximum recommended dose of Anagrelide Mylan is 2.5 mg at a time.

Question

How does Anagrelide Mylan work?

Answer

Essential thrombocythaemia is a disease in which the bone marrow produces too many platelets. This puts the patient at risk of developing blood clots or bleeding problems. The active substance in Anagrelide Mylan, anagrelide, blocks the development and growth of cells in the bone marrow called ‘megakaryocytes’, which produce platelets. This reduces the platelet count, helping to improve symptoms in patients with the disease.

Question

How has Anagrelide Mylan been studied?

Answer

Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Xagrid, and do not need to be repeated for Anagrelide Mylan.

As for every medicine, the company provided studies on the quality of Anagrelide Mylan. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.

Question

What are the benefits and risks of Anagrelide Mylan?

Answer

Because Anagrelide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.

Question

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

Answer

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

Question

Other information about Anagrelide Mylan

Answer

The European Commission granted a marketing authorisation valid throughout the European Union for Anagrelide Mylan on 15 February 2018.

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

Question

What is Anagrelide Mylan and what is it used for?

Answer

Anagrelide Mylan is a medicine used to reduce the number of platelets (components that help the blood to clot) in patients with essential thrombocythaemia (a disease in which there are too many platelets circulating in the blood). ‘Essential’ means that the disease has no obvious cause.

Anagrelide Mylan is used when the patient’s current treatment does not work well enough or has unacceptable side effects, and when they are ‘at risk’ because of their age (over 60 years), very high platelet counts or previous clotting problems.

Anagrelide Mylan contains the active substance anagrelide and is a ‘generic medicine’. This means that Anagrelide Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the European Union (EU) called Xagrid. Anagrelide Mylan is also a ‘hybrid medicine’ because it is available in an additional strength.

Question

Why is Anagrelide Mylan approved?

Answer

The European Medicines Agency concluded that, in accordance with EU requirements, Anagrelide Mylan has been shown to have comparable quality and to be bioequivalent to Xagrid. Therefore, the Agency’s view was that, as for Xagrid, the benefit outweighs the identified risk. The Agency recommended that Anagrelide Mylan be approved for use in the EU.

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