Dive Brief:
- GlaxoSmithKline's Nucala has been given the nod by the European Commission for a license extension as an add-on therapy for treating severe refractory eosinophilic asthma in children between six and 17 years of age.
- Nucala is now the first and only approved biologic therapy for pediatric patients with severe asthma that targets interleukin-5 (IL-5). It was first approved in 2015 in adults.
- The British pharma is counting on Nucala and other newer respiratory products to offset pricing pressures in the space and looming competition for its flagship Advair product.
Dive Insight:
Respiratory is a core focus for GlaxoSmithKline, but it's facing headwinds.
In a second quarter 2018 earnings, the pharma reported overall pharmaceutical sales fell 4% on an annual basis and respiratory sales dropped 6%, driven in part by a decline in Seretide/Advair (fluticasone propionate and salmeterol) sales and other medicines.
Advair sales are expected to fall further in late 2018 if a generic competitor is introduced. However, this could be offset by the company's new respiratory products.
The pharma saw 20% growth in the Ellipta franchise, including Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol), and 93% growth in Nucala (mepolizumab) during the second quarter. Breo Ellipta/Relvar Ellipta (fluticasone furoate/vilanterol) sales fell 15% in the U.S. but grew in Europe. Growth in the respiratory arena will be further driven by label expansions, such as Nucala's pediatric extension in the EU, as well as new indications.
"Nucala is continuing to build momentum too, with sales growth of over 100%, and we have increased our frontline investment in this growing market. Uptake in Europe is particularly strong, and we see further opportunity as we continue the launch rollout," GSK CEO Emma Walmsley said during the company's second quarter earnings call.
The company expects that its updated respiratory franchise, along with other new brands and label expansions should have a positive impact on its bottom line going forward — a turnaround that has been promised for some time.