Jan 13 (Reuters) – The U.S. Food and Drug Administration approved Fortress Biotech and Indian drugmaker Zydus Lifesciences’ drug for a type of rare genetic disease in children, Fortress said on Tuesday.
The drug, branded as Zycubo, is approved to treat Menkes disease, where patients are born without the ability to absorb copper from their diet. It is caused by mutations in a particular gene that is responsible for the transport of copper throughout the body.
The approval makes it the first drug on the market to treat this disease in the United States.
Symptoms of this condition include sparse and de-pigmented hair, seizures and developmental delays. If left untreated, many patients die between the ages of two and three years.
Fortress is eligible to receive tiered royalties on net sales of Zycubo and up to $129 million in aggregate development and sales milestones from Zydus.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Devika Syamnath)
