GSK looks to stand out in the severe asthma space with at-home injections for kids 6 to 11 years old
GlaxoSmithKline’s blockbuster Nucala may have been the first IL-5 drug to win marketing approval in severe asthma back in 2015, but newer rivals like AstraZeneca’s Fasenra have turned up the heat in recent years. Now GSK’s hoping an easier route of administration for kids will help set it apart from the pack.
The FDA on Monday approved a 40 mg prefilled syringe of Nucala for certain kids between 6 and 11 years old, meaning they can take the drug at home instead of trekking to the doctor’s office every four weeks. That makes a big difference for children with severe eosinophilic asthma (SEA), who may have trouble fitting in appointments around school and caregivers’ jobs, GSK’s US senior medical lead Tom Corbridge told Endpoints News.

“The ability to be much more flexible and allow for at-home administration through the prefilled syringe really is a terrific step forward, in my view, to help with less disruption in the life of an asthmatic child and their family,” Corbridge said. “It gives the opportunity to choose.”
Nucala was approved as an add-on maintenance therapy for kids and adults 12 years and older with SEA back in 2015, and GSK has been providing at-home administration options for these patients since 2019. The drug was also cleared that year for 6- to 11-year-olds, but those patients had to receive their injections by a physician until now.
SEA is caused by high levels of white blood cells called eosinophils. Nucala is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, diminishing blood eosinophils, but not eradicating them altogether, according to GSK (though Corbridge noted that the mechanism of action still hasn’t been fully elucidated). About 6 million children in the US have asthma, but only 2.5% to 5% of cases are characterized as severe. Nucala raked in $1.34 billion in 2020, snapping up an approval in hypereosinophilic syndrome (HES) that year, and another in chronic rhinosinusitis with nasal polyps (CRSwNP) in 2021.
But others — like AstraZeneca’s Fasenra and Teva’s Cinqair — are closing in. Fasenra netted $949 million in 2020 sales, and in September of that year AstraZeneca unveiled a positive batch of Phase III data in CRSwNP. While Nucala is administered every four weeks, patients on Fasenra receive 30 mg doses every four weeks for the first three doses, and once every eight weeks after that.
In 2018 — days after receiving a complete response letter in COPD — GSK released data pulled from 11 different studies suggesting that Nucala “significantly reduced clinically significant exacerbations and improved asthma control” compared to Fasenra and Cinqair, the other two anti-IL-5s in the severe asthma arena. Nucala is still the only anti-IL-5 approved for the 6 to 11 age group — but as of October, there’s also Sanofi and Regeneron’s Dupixent, which targets IL-4 and IL-13 and can be administered at home.
Regulators gave Dupixent a nod based on pivotal data that showed the drug reduced the rate of severe asthma attacks in kids 6 to 11 years old by an average of 65% over one year compared to placebo.
When asked what differentiates Nucala from competitors, Corbridge said it’s the breadth of available data.
“When you look at Nucala, mepolizumab, there’s an extensive data set that is available, not only clinical trials, controlled trials in patients, but also a number of open-label studies and real-world studies that extend into not only asthma, mostly in adults, but also in other eosinophilic driven diseases,” he said. “I would say that is certainly something we’re very proud of.”
So who’s eligible for the at-home pre-filled syringes? Corbridge says it’s a shared decision between physicians and caregivers. Patients who wish to receive their injections in person will still be able to do so. Since it was made available in 2019, Corbridge says a growing number of patients are opting for at-home versions of Nucala.
“That’s particularly important of course now in the era of Covid where, you know, at-home administration may also be preferable by patients, their families and even caregivers,” he said.
GSK’s also testing a long-acting IL-5 treatment dubbed GSK’294 for patients with SEA, which could potentially be administered once every six months. The pharma giant dosed the first patient in a Phase III study back in March, and is still awaiting the results.