Eton to offer generic Carbaglu

Eton Pharmaceuticals has acquired the U.S. marketing rights to carglumic acid tablets.

The product’s ANDA, which is owned by Novitium Pharma, was approved by the Food and Drug Administration on Oct. 13, 2021.

The product is the generic of Carbaglu.

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It is used to supplement treatment of acute high blood ammonia levels (hyperammonemia) due to NAGS deficiency, propionic acidemia, and methylmalonic acidemia, and to treat chronic high blood ammonia levels due to NAGS deficiency.

“We are pleased to be offering patients a lower cost alternative to one of the most expensive treatments in the world,” said Sean Brynjelsen, Eton’s CEO. “With our existing orphan drug commercial footprint and robust patient support services, we believe we are well positioned to commercialize this product. We look forward to working with Novitium to bring the product to patients later this year.”

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Carbaglu is widely regarded as one of the highest priced pharmaceutical products in the world, with the annual cost of treatment estimated to exceed $1 million for many patients. The introduction of Eton’s lower cost alternative is expected to save patients and the U.S. healthcare system millions of dollars annually.