Analyst Notes: Will Nucala and Cinqair rain on Xolair's parade in the targeted asthma market?

With a new treatment for severe, uncontrolled asthma coming to market, and several pipeline therapies delivering impressive late-stage clinical data, in 2016, what does the future hold for category leader Xolair (omalizumab; Roche/Novartis)?

Teva's Cinqair/Cinqaero (reslizumab) and GlaxoSmithKline's Nucala (mepolizumab) have emerged as significant threats to Xolair's dominance, so what can Roche and Novartis do to stop the rot? Will clinical data save the day, or will commercial tactics be the critical difference in a rapidly evolving market?

A new report from FirstWord called KOL Insight: Targeted Therapies in Asthma, provides key opinion leader (KOL) insight on these and other issues that are set to dominate discussions.

Insight, Analysis and Opinion

The treatment of severe, uncontrolled asthma looks set for a shake-up. Xolair is no longer the only biologic treatment for this indication; it's unique status disappearing when GlaxoSmithKline's Nucala and Teva's Cinqair/Cinqaero were approved in 2015 and 2016, respectively. A key question, therefore, is will Xolair remain the treatment of choice for allergic asthma patients?

Xolair may remain a first-line therapy for allergic asthma patients with elevated serum IgE levels, but for some patients, other treatment options, like Nucala and Cinqair/Cinqaero, might be a better strategy.

Roche and Novartis aren't giving up, however. In July 2016, Xolair was awarded a paediatric allergic asthma label, an event that KOLs labeled as "long overdue." But will it enable Roche and Novartis to drive future clinical differentiation? Perhaps, argue KOLs, but only time will tell if how Xolair is positioned in this patient population has had any impact.

"It's long overdue; we've been waiting for it for a long time. It opens Xolair up to a nice population of patients who I think have the greatest benefit. This is a more effective drug in children than it ever has been, or will be, in adults and I don't think we've even seen close to what it's really capable of." - US Key Opinion Leader

Looking longer-term, what pipeline programmes are KOLs most excited about? Are next-generation anti-IL5 monoclonal antibodies (mAbs), including benralizumab (AstraZeneca) set to change the course of the severe asthma treatment market, or will it be the anti-IL-4/IL-13 mAbs, like dupilumab (Regeneron Pharmaceuticals /Sanofi)?

KOLs were very impressed with Phase II data for dupilumab, released in May 2015, with some suggesting that it was the best data they'd seen in severe, uncontrolled asthma patients for many years. That being said, late-stage data is needed before a firmer opinion on the drug can be formed.

"It really had a very marked effect on exacerbations and on lung function actually. If that efficacy holds up in Phase III studies, then it looks pretty promising to me." - European Key Opinion Leader

"I think that it [dupilumab] will probably have a broader usage. They're basically looking to make it independent of biomarker requirements, making it easier to prescribe. If you've got poor control, then why waste your time and money doing biomarker testing? Just give dupilumab if it works on everybody." - US Key Opinion Leader

KOL Insight: Targeted Therapies in Asthma gives balanced and independent insights into what North American and European KOLs think about these and other issues, including biosimilars and biomarkers, and how the treatment paradigm for severe, uncontrolled asthma is likely to evolve.

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