Micrograph showing thalassemia
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Deferiprone Lipomed to treat iron overload in patients with thalassemia major.
Deferiprone Lipomed is a generic version of the iron chelating agent Ferriprox, which has been authorized in the European Union since August 1999.
According to the CHMP, studies have shown that Deferiprone Lipomed is of satisfactory quality and bioequivalent to Ferriprox.
The CHMP’s recommendation for Deferiprone Lipomed will be reviewed by the European Commission, which has the authority to approve medicines for use in the European Union, Norway, Iceland, and Liechtenstein.
The European Commission usually makes a decision within 67 days of the CHMP’s recommendation.
If approved, Deferiprone Lipomed will be available as 500-mg film-coated tablets.
The drug will be authorized for the following uses:
- As monotherapy to treat iron overload in patients with thalassemia major when current chelation therapy is contraindicated or inadequate
- In combination with another chelator in patients with thalassemia major when monotherapy with any iron chelator is ineffective or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction.
According to the prescribing information for Ferriprox, the combination of iron chelators should be considered on a case-by-case basis, and patients should be monitored for response and adverse events.
Fatalities and life-threatening situations (caused by agranulocytosis) have been reported with the combination of deferiprone and deferoxamine.
Combination therapy is not recommended when monotherapy with either chelator is adequate or when serum ferritin falls below 500 μg/l. Additionally, there are limited data on the combined use of Ferriprox and deferasirox.
The applicant for Deferiprone Lipomed is Lipomed GmbH.