Analyst Notes: GlaxoSmithKline's Nucala breaths life back into the severe asthma treatment landscape

GlaxoSmithKline's Nucala (mepolizumab), an anti-IL-5 antibody, represents a significant treatment advance in the asthma market. Clinical data show that it can significantly reduce exacerbations in a sub-set of asthmatics (patients with severe, refractory asthma who have an eosinophilic phenotype) who currently have limited treatment options. But are physicians impressed, and how readily will it be adopted? Leading respiratory key opinion leaders (KOLs) speak out on Nucala's chances, plus several other key developments in the severe asthma treatment space, in FirstWord's new report KOL Insight: Targeted Therapies in Asthma.

Insight, Analysis & Opinion

Nucala was approved in the US in November 2015 as an add-on maintenance treatment for patients ages 12 years or older with severe asthma that have an eosinophilic phenotype. Approval in Europe followed soon after in December for the same indication, but only in adult patients. So far, KOLs are impressed and believe that Nucala is likely to be used extensively in this patient population.

"We have a number of patients who have severe asthma who are not treated well with existing therapies. They have high eosinophilia despite corticosteroid therapy, and Nucala seems to be very effective and also very safe. There is no doubt they will be major advantage in the treatment of severe asthma." - EU Key Opinion Leader

"Anti-IL-5 mAbs are all capable of reducing exacerbations on top of standard therapy. That's an advance and it is additive to what we already have, and it allows you to do it in a population that is different to the Xolair population." - US Key Opinion Leader

Patient dynamics seem to be playing a role in Nucala's ascendency, as there appears to be a substantial population of readily identifiable patients who may be candidates for anti-IL-5 antibody treatment. Critically, the approved indications for Nucala in Europe and the US do not specify a minimum blood eosinophil level for treatment, thereby enabling a wide range of patients to become eligible for treatment. KOLs do urge caution, however, when trying to predict the uptake of Nucala. Although many patients with severe asthma could be eligible, it won't necessarily mean that Nucala will be prescribed, particularly in patients at the lower end of the blood eosinophil range.

"I would not prescribe mepolizumab [Nucala] for a patient with 150 cells/μL as most of those patients do not have uncontrolled asthma. A minimum eosinophil number to start mepolizumab treatment is 300 or 400 cells/μL." - EU Key Opinion Leader

That being said, data from the British Thoracic Society Severe refractory Asthma Registry suggest that 15 percent of asthma patients could be eligible for Nucala therapy, which is a sizeable target population. On the basis of these patient numbers, multi-billion sales estimates could become a reality assuming GlaxoSmithKline is able to command the $32,500 per year price tag.

KOL Insight: Targeted Therapies in Asthma gives balanced and independent insights into what North American and European KOLs think about marketed and pipeline products for the treatment of severe, refractory asthma. The report provides expert assessment and perception of these therapies, as well as discussing usage changes for current/pipeline products. Importantly, the KOLs stipulate which agents are most promising and how the treatment paradigm is expected to change in the future.

To read more Analyst Notes articles, click here.