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

3-Day Conference

6th Promotional Review Committee Compliance & Best Practices Conference

The leading U.S. event devoted to building the skills, speed and teamwork of your promotional review committee members will take place May 15–17, 2019 in Chicago. The conference is set to bring together more than 75 professionals to ensure your PRC is prepared to generate, collect and constructively act on expert comments for your entire drug and device portfolio.

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

Sanofi is working on a succession plan for CEO Olivier Brandicourt, who'll hit mandatory retirement age in 2021.

Gilead CEO John Milligan racked up $26M in 2018 pay, on paper at least, while incoming chief Daniel O'Day is in line for a cool $30M this year.

Novo Nordisk has at least four more years to build up its newer diabetes drugs before they face Teva's versions of its $2.67B blockbuster Victoza.