As rivals crowd in, can Novartis' Xolair remain a blockbuster? New sinusitis data could help

Novartis’ Xolair, long a leader in the blockbuster-heavy severe asthma field, has been feeling pressure on all sides as serious competitors continue to neuter the drug’s head start. Positive data in sinusitis could offer some breathing room.

Six months of treatment with Xolair reduced congestion and nasal polyps compared with placebo in adults with chronic sinus problems who previously tried nasal steroids, according to data from two phase 3 studies, dubbed Polyp 1 and Polyp 2, released Monday.

“This is an important and exciting milestone for Xolair, which continues to help thousands of people around the world with severe allergic asthma and chronic spontaneous urticaria," said John Tsai, Novartis’ R&D chief.

Novartis could use all the help it can get fending off powerhouse challengers in asthma, including GlaxoSmithKline’s Nucala, Teva’s Cinqair and AstraZeneca’s Fasenra—not to mention its new rival, Sanofi and Regeneron's Dupixent, which launched late last year. Xolair, which first hit the U.S. market in 2003, is approved to treat moderate to severe allergic asthma and chronic hives and was long a catch-all drug for rare asthma patients before more targeted drugs hit the market.

But even as more challengers enter the field, Xolair has renewed its push into new indications, including peanut allergies, and has reaped modest rewards growth-wise. In the first quarter, Xolair posted $281 million in sales, a 10% increase over the same period the previous year.

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But those sales are actively being challenged by fast-growing competitors like Fasenra, which grew an astronomical 514% in first-quarter sales to $129 million, and Dupixent, which grew 187% to just less than $370 million. Meanwhile, old foe Nucala, which boasts impressive switching data over Xolair, posted $192 million in sales.

And specifically in nasal polyps, Xolair is chasing Dupixent, which received an FDA priority review for sinusitis in March. Analysts said the drug could reach $2.5 billion in peak asthma sales, far outpacing the rest of the field by riding a broad label and safety data that outclasses the competition.

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With so many obstacles in Xolair’s path, Novartis is pushing a follow-up competitor in hopes that a successor could eventually absorb the blockbuster drug’s sales. In December, the Swiss drugmaker advanced candidate ligelizumab in chronic hives to phase 3 on the back of study data showing superiority over Xolair. As part of its phase 2 study, ligelizumab demonstrated a clear dose-response relationship and improvement on Xolair's performance in patients whose symptoms weren’t controlled with H1-antihistamines­, Novartis said.