Chiesi gains FDA approval for Ferriprox twice-daily tablets

The US Food and Drug Administration has approved Ferriprox (deferiprone) twice-a-day tablets for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate, to be marketed by the US subsidiary of family-controlled Italian drugmaker Chiesi Farmaceutici.

“The availability of a new twice-a-day oral tablet formulation of Ferriprox provides patients with the ability to reduce serum ferritin levels and cardiac and liver iron,” said Giacomo Chiesi, head of Chiesi Global Rare Diseases, adding: “This important milestone for Chiesi Global Rare Diseases is another reflection of our commitment to innovation to improve the lives of patients living with rare diseases around the world.”

Having already been a distributor for drug in Italy, Brazil, Turkey and certain other countries, in January 2020, Chiesi acquired the worldwide marketing rights for Ferriprox for the treatment of transfusional iron overload due to thalassemia syndromes, from ApoPharma, the US subsidiary of Canadian company Apotex.

Thalassemia syndromes are a group of rare inherited hematological conditions including beta-thalassemia and are characterized by impaired hemoglobin production. In certain cases, such as with beta-thalassemia, severe forms of this genetic disorder if left untreated can lead to life-threatening complications. Patients are often managed with long-term blood transfusions that can put them at risk of developing very high levels of iron in their blood and vital organs.