Novartis says asthma blockbuster Xolair also effective against serious hives

Hives may sound like a mundane condition, but it can carry some significant symptoms for those who suffer from chronic spontaneous urticaria (CSU). It is a particularly nasty form of hives that can cause sufferers to lose sleep and have anxiety and even depression. Novartis ($NVS) says its asthma drug Xolair can provide help, and if approved, it would add some sales to the shared blockbuster at a time when Novartis is scrambling to make up for patent losses.

Currently patients with CSU must rely on antihistamines, which don't work for about half of them, Pharma Times reports, even for those who take four times the approved dose. But results of a Phase III study published by Novartis found that more than 33% of those with CSU taking omalizumab had their itching resolved after 12 weeks compared to 5% on a placebo. Fifty-two percent of patients reported well-controlled symptoms in the same time period, compared with 12% of those taking the placebo.

Novartis partners with Roche's ($RHHBY) Genentech on Xolair, which Novartis reports has worldwide sales of more than $1 billion. But Novartis says in financial filings that its pricing is under pressure for the asthma treatment. In the U.K., the price watchdog NICE last fall indicated it might drop approval of the drug there but then relented in March after Novartis offered up an undisclosed discount for the treatment. Prediscount, the annual cost can run anywhere from £1,665 to £26,640, or about $2,500 to $40,140, depending on the severity of the case. New data also convinced the regulatory committee to recommend the treatment for children under the age of 12.

Novartis says the companies expect to seek approval for the CSU indication this year. Novartis could use it, given the pressure on its earnings from patent losses for drugs like antihypertension treatment Diovan. Novartis reported sales of $504 million for Xolair outside the U.S. last year. In the U.S., it shares operating revenue with Genentech but does not record any sales. Patents on the drug lapse in Europe in 2017 and a year later in the U.S. The companies are also conducting a study in China and expect to seek approval for the drug there.

- here's the release
- read the Pharma Times story