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AbbVie's Humira wins ninth US approval

FDA approves multi-blockbuster for inflammatory skin disease
AbbVie Humira

AbbVie's Humira has been approved as the first and only drug for a chronic skin disease, hidradenitis suppurativa, making it the drug's ninth approved indication in the US.

Hidradenitis suppuritiva (HS) is a chronic inflammatory skin disease typically characterised by lesions around armpits, groin, on the buttocks or under the breasts.

The approval is based on data from two phase III trials - Pioneer I and Pioneer II - which included 633 people with moderate to severe HS.

Both studies showed that more patients given Humira (adalimumab) had reductions in total number of abscesses and inflammatory nodules than patients who received placebo.

Alexa Kimball, principal investigator in the trials, said: “The symptoms of HS 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.”

In July the European Commission also approved Humira for the treatment of HS for those with an inadequate response to conventional treatment giving the drug its thirteenth license in Europe.

Humira was the world's largest selling drug in 2014, raking in $13bn and now has approval in over 87 countries and is being used to treat roughly 850,000 patients worldwide.

However, AbbVie's drug will soon face stiff competition from biosimilars with Amgen, Novartis' Sandoz unit and Boehringer Ingelheim all planning to launch their own versions of Humira, which is due to lose patent protection in 2016 in the US and in 2018 across Europe.

At the end of last year, patients in India were the first to receive a Humira biosimilar launched by Indian company Zydus Cadila.

Article by
Nikhil Patel

14th September 2015

From: Sales, Regulatory

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