Novartis' allergic asthma treatment Xolair could find a new role as a treatment for an allergic skin disease after encouraging results in a phase III trial.
The active ingredient in Xolair (omalizumab) has been found to be effective as a treatment for a chronic and debilitating form of hives known as chronic spontaneous urticaria (CSU) in the study, reinforcing the findings of two earlier trials.
Novartis filed for approval of omalizumab a few weeks ago as a treatment for CSU, which is known as chronic idiopathic urticaria (CIU) in the US and has no approved treatment other than antihistamines. Current treatment generally has limited efficacy and often has to be given in very high doses to control symptoms.
The latest trial - called ASTERIA 1 - showed that patients treated with omalizumab had significantly less itching and reported improved quality of life compared to the placebo group, with benefits seen as early as one week after starting treatment. The alleviation of itch was sustained over 24 weeks, according to Novartis.
Omalizumab has already been a useful earner for Novartis for some time, with the Xolair asthma product posting sales of $289m in the first six months of the year, a 21 per cent increase on the same period of 2012.
Novartis has not suggested how much upside approval in CSU could have for the omalizumab franchise, although the company's head of pharmaceuticals David Epstein said earlier this year it is likely to be "substantial".
"This is a disease that is not well known by many, but devastating for patients," he said during the company's second-quarter results call.
"These patients … have severe itching [and] have angioedema. They very often cannot work and live in constant fear of unexpected attacks," noted Epstein.
He also pointed out that omalizumab sits well alongside Novartis' new psoriasis candidate secukinumab as the foundations of an interesting dermatology franchise.
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