FDA Approves Twice-Daily Form of Ferriprox

A new formulation of the oral chelator Ferriprox, which is intended to be taken twice a day, has been approved for use in the United States by the U.S. Food and Drug Administration.  The previously approved formulation was to be taken three times daily; the new formulation eliminates the mid-day dose.

“In the management of patients with thalassemia, clinicians often see firsthand the difficulties they can have with dosing and compliance, and the impact that this can have on the effectiveness of treatment,” said Thomas Coates, M.D. Section Head, Hematology at Children’s Hospital Los Angeles, in a press release concerning the approval. “A treatment option that reduces serum ferritin, cardiac iron and liver iron with an established safety profile and now twice-a-day tablet dosing can represent a significant advantage for patients.”

Ferriprox (twice-a-day) is an iron chelator indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.  Previously manufactured by ApoPharma, Ferriprox was acquired recently by Chiesi Farmaceutici S.pA.,  and is now part of  Chiesi Global Rare Diseases.

“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 via press release.  “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.”

To support patients treated with Ferriprox (twice-a-day), Chiesi Global Rare Diseases offers the Chiesi Total Care™ Program. Through this program, healthcare providers and patients can access a team of dedicated specialists able to provide individual support as well as information about prescription, reimbursement, financial assistance and product refills. For information about Chiesi Total Care, call 866-758-7071.

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