AbbVie’s Humira meets endpoint in eye disease study
pharmafile | May 6, 2015 | News story | Research and Development, Sales and Marketing | AbbVie, FDA, Humira, Zydus Cadila, adalimumab, uveitis
In a Phase III trial AbbVie’s anti-inflammatory medicine Humira has been shown to significantly lower the risk of uncontrolled uveitis or vision loss.
Once the world’s best selling drug, Humira (adalimumab) was being studied in adult patients with active non-infectious intermediate, posterior, or panuveitis who still experienced intraocular inflammation while on systemic corticosteroid therapy.
“Backed by nearly two decades of experience with Humira, AbbVie continues to drive for innovative solutions in inflammatory disease with a strategic focus on developing new treatment strategies for conditions with high unmet needs,” says Scott Brun, who is the VP of pharmaceutical development at AbbVie.
He adds that the results from its VISUAL-I study mark a commitment to patients with a wide range of immune-mediated disorders, and that they’ll also be looking towards extending Humira’s use as a potential treatment option for patients living with particular forms of uveitis.
This time last year AbbVie received orphan drug designation from the FDA for the investigational treatment of certain forms of non‑infectious uveitis with Humira.
Non‑infectious uveitis is a group of diseases characterised by inflammation of the eye that is often chronic, can lead to reduced vision or vision loss and are commonly treated by a specialised opthalmologist.
Symptoms may include vision loss, blurred vision, eye pain and redness, as well as sensitivity to light – and it is estimated that non‑infectious and infectious uveitis together account for up to 15% of all cases of vision loss in the US.
Whilst the drug is not currently approved to treat any form of uveitis, US and EU regulatory submissions are expected to take place this year. Crucially the US patent on the drug expires in December 2016 so the firm will be keen to see its use extended in more settings.
Late last year Indian firm Zydus Cadila launched the first biosimilar of AbbVie’s anti-inflammatory offering as a treatment in various forms of arthritis and ankylosing spondylitis.
“Currently, there are limited treatment options for patients with non-infectious uveitis, a potentially blinding condition,” says Glenn Jaffe from Duke University, Durham in the US.
“These results provide data about the potential clinical benefits of Humira as a treatment option for patients living with particular forms of uveitis.”
Brett Wells
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