Novartis, aiming to protect blockbuster sales, advances Xolair follow-up to phase 3

Novartis headquarters
Novartis' Xolair pulled in $1.75 billion last year, thanks in part to its chronic hives indication. (Wikimedia Commons/Andrew/Flickr)

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.

RELATED: Glaxo aims to lure patients from Novartis' Xolair with Nucala switching study

Whitepaper

Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

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.

RELATED: Roche, Novartis grab FDA OK for new version of aging blockbuster Xolair

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.

Suggested Articles

The FDA has granted Amarin's Vascepa a possible blockbuster label expansion for CV risk reduction in patients with or without CV disease.

In a high-stakes patent lawsuit between CAR-T companies Bristol-Myers Squibb and Gilead Sciences, BMS has come up with a victory. 

It’s been a year of ups and downs for Pfizer’s Xeljanz. But the company is hoping to close on a high note, with help from a new extended-release pill.