With blockbuster Xolair aging, Novartis is looking to usher in a successor to protect its sales. And it got one step closer this week.
The Swiss drugmaker will advance candidate ligelizumab—a treatment for chronic spontaneous urticaria, or hives—into phase 3 on the back of Xolair-topping phase 2 results. In a head-to-head showdown, the prospect showed it could demonstrate a clear dose-response relationship, as well as improve on Xolair's performance, in patients whose symptoms weren’t adequately controlled with H1-antihistamines.
Now, Novartis is plotting a pair of phase 3 trials, dubbed Pearl 1 and Pearl 2. The studies will enroll more than 2,000 CSU patients, making them the largest pivotal trials to date in the disease.
The timing is good for Novartis, which has already lost patent protection on the original formulation of Xolair in both the U.S. and EU, although biosimilar rivals have yet to show up.
That doesn’t mean other drugs haven’t been chipping away at its share, though. In the med’s other indication, severe asthma, a new group of biologics specifically indicated for severe eosinophilic asthma—including AstraZeneca’s Fasenra and GlaxoSmithKline’s Nucala—have swooped in to lure Xolair patients away with more targeted therapy. And a brand new indication for Sanofi’s quick-launching Dupixent is set to challenge Xolair further in that department.
Novartis, though, isn’t taking the new competition lying down. It’s doing all it can to preserve Xolair’s sales, which in the U.S. checked in at $1.75 billion last year. In October, the company and its partner, Roche, welcomed an FDA green light for a prefilled syringe formulation of Xolair, which will save doctors from having to reconstitute the treatment before use.
The Basel-based duo is also gunning for a new use in food allergies after picking up the FDA’s breakthrough designation in August.