AbbVie Posts Another Win for Humira

Health and Healthcare

Published: September 10, 2015 4:18 pm

Last Updated: April 27, 2020 3:09 pm

AbbVie Inc. (NYSE: ABBV) has continued to push forward over the past year and shares are actually up 7.3% in the past 52-weeks despite the markets pulling back in August. Late Thursday, the company won a key battle in its pipeline going forward. The company announced that the U.S. Food and Drug Administration (FDA) approved Humira (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS). Humira is now the first and only FDA-approved therapy for adults with HS.

For some background, HS is a chronic inflammatory skin disease characterized by inflamed, painful lesions typically located around the armpits and groin, on the buttocks and under the breasts.

Earlier in 2015, Humira was granted an orphan drug designation for the treatment of moderate to severe HS. The orphan drug designation provides Humira the potential to be granted seven years of market exclusivity for the treatment of moderate to severe HS.

Alexa Kimball, M.D., M.P.H., director of the Clinical Unit for Research Trials and Outcomes in Skin at Massachusetts General Hospital, professor of dermatology at Harvard Medical School and principal investigator, commented on the approval:

The symptoms of HS, including inflamed nodules and abscesses, can have a significant impact on patients during their most active years of life. Adalimumab significantly reduced the signs of HS in clinical trials, and this FDA approval provides a much needed development in treatment options for patients.

Michael Severino, M.D., executive vice president, research and development and chief scientific officer of AbbVie, also said:

We are pleased that people living with hidradenitis suppurativa now have an FDA-approved treatment option for this chronic, debilitating disease. AbbVie is committed to making a remarkable impact on the lives of patients, and hidradenitis suppurativa is an area of particular unmet need.

Shares of AbbVie closed Thursday up 0.5% at $59.58 on its 52-week trading range of $52.06 to $71.60. The stock has a consensus analyst price target of $76.36.

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