Shire gets FDA approval for primary immunodeficiency drug

The US Food and Drug Administration has granted approval for Shire’s Cuvitru drug for the treatment of patients with primary immunodeficiency, which is a group of more than 300 genetic disorders.

Shire said it expects to launch the drug in the US in the coming weeks. It was already approved in 17 European countries in June.

The specialty biopharmaceutical group said that with this FDA approval, it now has the broadest portfolio of intravenous and subcutaneous immunolglobulin products, including the only once-a-month subcutaneous treatment option.

Perry Sternberg, head of US Commercial at Shire, said: “As Cuvitru is now approved in the US following European approval earlier this year, Shire’s broad IG treatment portfolio offers a wide range of options to help physicians tailor treatment regimens to meet the priorities of their patients managing these life-long disorders.”

At 1500 BST, Shire shares were up 2.1% to 4,909p.