Novartis has taken a step towards expanding the indications for its severe asthma drug Xolair after it was recommended for EU approval to treat a skin disease.
The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Xolair (omalizumab) for a chronic and debilitating form of hives known as chronic spontaneous urticaria (CSU).
Based on the results of a phase III trial the drug has been backed to treat CSU as a monthly subcutaneous injection in patients aged over 12 as an add-on to standard treatment with antihistamines and – in severe cases – corticosteroids. Around half of all CSU patients do not respond even to high-dose antihistamine therapy.
As an asthma therapy Xolair has steadily grown to become a major product for Novartis, with sales rising 20 per cent to $440m in the first nine months of 2013, and the addition of CSU could help usher the drug into blockbuster territory.
Chronic urticaria affects around 1 per cent of the world’s population, and CSU accounts for around two-thirds of patients, and Novartis estimates that 1.6 million people are diagnosed in the US and EU alone, with around 70,000 refractory to all available therapies.
“If approved, Xolair will be the first and only licensed therapy in the EU for up to 50 per cent of CSU patients not responding to approved doses of antihistamines,” commented Tim Wright, global head of development at Novartis’ pharmaceuticals division.
Novartis has said it sees particular promise in immunological therapies for skin disease, and indicated recently that Xolair and its psoriasis candidate secukinumab could collectively provide peak sales of $2bn-$3bn a year.
David Epstein, head of pharmaceuticals at Novartis, described CSU in graphic terms at an investor presentation last year.
“The attacks … can result in sloughing in the skin, hives, itching, sometimes eyes that are shut, lips that are swollen, loss of airway [and the] ability to breathe,” said Epstein. “CSU leaves patients in constant fear of when the next attack is going to occur,” he added.