Results from a Phase III open-label extension trial showed that the safety and efficacy profile observed in previous Dupixent trials were maintained for up to three years in adults and adolescents with moderate-to-severe asthma.
Since taking over Sanofi, Chief Executive Officer Paul Hudson has seen enormous potential in Dupixent. Hudson has suggested the drug co-developed with Regeneron could drive about $12 billion in annual revenue. Long-term safety and efficacy data released this morning underscores that potential for the biologic as the two companies eye future indications.
Sanofi and Regeneron said results from a Phase III open-label extension trial showed that the safety and efficacy profile observed in previous Dupixent trials were maintained for up to three years in adults and adolescents with moderate-to-severe asthma. Data from the trial will be presented during a live session at the virtual 2020 European Respiratory Society (ERS) International Congress. The analysis includes data from more than 2,200 patients who previously participated in Dupixent asthma trials, including three pivotal trials that lasted between 24 and 52 weeks.
Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) and atopic dermatitis. In the United States, Dupixent has been approved for use with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older whose asthma is not controlled with their current asthma medicines. Dupixent is approved for additional uses in certain patients with atopic dermatitis and CRSwNP.
When it comes to the efficacy in treating asthma, the long-term data presented at the Congress is impressive. Over the course of three years, the patients experienced improved lung function by 13-22% compared to baseline. Patients also maintained a lower rate for severe asthma attacks. Sanofi and Regeneron said those patients had an average of 0.31-0.35 events per year. Prior to treatment with Dupixent, the patients had an annual 2.09-2.17 rate for severe asthma attacks.
When it comes to treating type 2 inflammation, the studies showed that improvements in lung function and asthma attacks were greater in those with elevated baseline blood eosinophils or fractional exhaled nitric oxide (FeNO), which are markers of type 2 inflammation. Patients showed 22-35% reductions in blood eosinophils.
When it comes to safety, Dupixent maintained similar safety results consistent with those seen in previous studies. Serious adverse events were only seen in 9% to 13% of patients in the study, the companies said.
Michael Wechsler, director of the National Jewish Cohen Family Asthma Institute in Denver, Colorado, and principal investigator of the trial, said the data presented at the congress suggest Dupixent may slow the progressive decline in lung function that many patients with moderate-to-severe asthma experience, as shown by the sustained improvement in lung function for up to three years.
“Further, patients on Dupixent maintained asthma control and reduced rates of severe asthma attacks that may result in hospitalizations. This reinforces the importance of Dupixent as a continuous, long-term treatment option to improve patients’ ability to breathe and maintain control of their asthma, particularly in those with higher markers of underlying type 2 inflammation,” Wechsler said in a statement.
