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news.AbbVie has received orphan drug designation from the US Food and Drug Administration (FDA) for Humira (adalimumab) to treat moderate-to-severe hidradenitis suppurativa (HS) (Hurley Stage II and Hurley Stage III disease).
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HS, referred to as acne inversa, is a painful, chronic inflammatory skin disease for which there is no known cure and no approved medication.
It is characterized by inflamed areas located around the armpits and groin, between the buttocks and under the breasts.
The company said that Humira is a TNF blocker medicine that affects the immune system and can lower the body’s ability to fight infections.
AbbVie pharmaceutical development vice-president Scott Brun said: "Patients living with hidradenitis suppurativa have limited treatment options and often experience severe, painful symptoms that can significantly impact their lives.
"We are committed to researching treatment options to address the unmet needs of the dermatology community and we are pleased that the FDA has issued this designation and recognizes the treatment potential of Humira."
The company’s supplemental Biologic License Application (sBLA) seeking approval for the use of Humira in patients with moderate-to-severe HS is currently under review with the FDA.
Currently, Humira is not approved by regulatory authorities for the treatment of HS.