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The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Anagrelide Mylan.
The product is intended to reduce elevated platelet counts in at-risk patients with essential thrombocythemia (ET).
Anagrelide Mylan is a generic of Xagrid (0.5 mg hard capsules), which has been authorized in the European Union since November 2004.
The active substance of Anagrelide Mylan is the antineoplastic agent anagrelide.
The precise mechanism by which anagrelide reduces platelet counts is unknown. Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III.
If authorized, Anagrelide Mylan will be available as 0.5 mg and 1 mg hard capsules.
The full indication for the drug will be to reduce elevated platelet counts in at-risk 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 ET patient is defined by 1 or more of the following features:
- Age older than 60
- Platelet count greater than 1000 x 109/L
- A history of thrombo-hemorrhagic events.
The CHMP’s opinion on Anagrelide Mylan will be reviewed by the European Commission (EC).
If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the European Union. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.
The EC typically makes a decision within 67 days of the CHMP’s recommendation. 
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Anagrelide Mylan.
The product is intended to reduce elevated platelet counts in at-risk patients with essential thrombocythemia (ET).
Anagrelide Mylan is a generic of Xagrid (0.5 mg hard capsules), which has been authorized in the European Union since November 2004.
The active substance of Anagrelide Mylan is the antineoplastic agent anagrelide.
The precise mechanism by which anagrelide reduces platelet counts is unknown. Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III.
If authorized, Anagrelide Mylan will be available as 0.5 mg and 1 mg hard capsules.
The full indication for the drug will be to reduce elevated platelet counts in at-risk 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 ET patient is defined by 1 or more of the following features:
- Age older than 60
- Platelet count greater than 1000 x 109/L
- A history of thrombo-hemorrhagic events.
The CHMP’s opinion on Anagrelide Mylan will be reviewed by the European Commission (EC).
If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the European Union. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.
The EC typically makes a decision within 67 days of the CHMP’s recommendation.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for Anagrelide Mylan.
The product is intended to reduce elevated platelet counts in at-risk patients with essential thrombocythemia (ET).
Anagrelide Mylan is a generic of Xagrid (0.5 mg hard capsules), which has been authorized in the European Union since November 2004.
The active substance of Anagrelide Mylan is the antineoplastic agent anagrelide.
The precise mechanism by which anagrelide reduces platelet counts is unknown. Anagrelide is an inhibitor of cyclic AMP phosphodiesterase III.
If authorized, Anagrelide Mylan will be available as 0.5 mg and 1 mg hard capsules.
The full indication for the drug will be to reduce elevated platelet counts in at-risk 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 ET patient is defined by 1 or more of the following features:
- Age older than 60
- Platelet count greater than 1000 x 109/L
- A history of thrombo-hemorrhagic events.
The CHMP’s opinion on Anagrelide Mylan will be reviewed by the European Commission (EC).
If the EC agrees with the CHMP, the commission will grant a centralized marketing authorization that will be valid in the European Union. Norway, Iceland, and Liechtenstein will make corresponding decisions on the basis of the EC’s decision.
The EC typically makes a decision within 67 days of the CHMP’s recommendation.