Still waiting for a key FDA decision in asthma, Sanofi and Regeneron’s Dupixent has cut in with positive clinical results in adolescents with atopic dermatitis, an indication in which it’s currently approved for adults.
When used alone, the type 2 inflammation drug demonstrated significant improvement in teenagers aged 12 to 17 with atopic dermatitis, according to phase 3 results detailed at the European Academy of Dermatology and Venereology Congress in Paris.
About 41.5% of patients receiving Dupixent every two weeks and 38% of those on an every-four-week schedule saw skin improvement of 75% or greater, compared to 8% for placebo. Using a different criterion to assess the results, about every 1 in 4 patients who got weight-based dosing every two weeks achieved clear or almost-clear skin, versus 2% for those on a dummy drug. Plus, some additional secondary endpoints were also met.
For these teenagers with moderate-to-severe eczema, topical therapies are either unable to control the disease or are simply not applicable. The new results show Dupixent can “not only help clear the skin and reduce itching, but also improve certain aspects of quality of life in adolescents who may be dealing with these unbearable symptoms,” said Amy Paller, M.D., of Northwestern University and principal investigator of the trial.
The partners now hope the readouts could serve as the basis of regulatory submissions in this age group, and it is also looking to file for approval in children as young as six in the second half of 2019.
But perhaps more important for them is an FDA decision expected next month on asthma, an indication analysts at Bernstein predicted could add $2.5 billion in peak sales for the drug.
In a previous phase 3 on more than 1,900 patients, including adults and adolescents, the drug, when compared to standard therapies, reduced severe asthma attacks by 46% in all patients. What’s more, it also improved lung function. Even though the benefit was greater among patients with high levels of eosinophilic cells, management has said they expect an approval regardless of eosinophils level.
The Dupixent launch has been going well for the companies, as sales reached €176 million ($206 million) during the second quarter. Total prescriptions in the U.S. also grew 27% sequentially, and patient initiations were growing on a weekly speed of more than 800 patients, said Genzyme chief Bill Sibold on the second-quarter earnings call.
However, competition is coming for both those indications. AbbVie recently posted full positive atopic dermatitis results for its JAK1 inhibitor upadacitinib, while AstraZeneca and Amgen’s tezepelumab was granted an FDA breakthrough designation in severe asthma without an eosinophilic phenotype.