Sanofi and Regeneron’s Dupixent has notched another indication in the EU, this time for a common lung disease, marking the first-ever targeted therapy for the condition in the region.
The French drugmaker said the EMA greenlit Dupixent as an “add-on maintenance treatment” for adults with uncontrolled chronic obstructive pulmonary disease (COPD) and raised blood eosinophils. The approval unlocks a market of more than 200,000 patients in the EU, according to a Wednesday release.
In the US, Dupixent’s path to COPD approval has proven more challenging, with the FDA requesting more efficacy analyses back in May of subgroups from the drug’s registrational studies, BOREAS and NOTUS. Weeks later, the agency delayed Dupixent’s PDUFA date by three months, with a decision now expected by Sept. 27 in place of the original June date.
At the time, Sanofi and Regeneron said the FDA “did not raise any concerns regarding the approvability of Dupixent for this indication,” and added they were confident the additional analyses they provided “strongly support” approval. The drug is also under review in China and Japan.
Dupixent is approved in five indications in the US and is used by 850,000 patients worldwide. In the first three months of the year, its sales jumped 24.9% from the same period in 2023 to €2.84 billion ($3.06 billion), putting it ahead of the former immunology bestseller, AbbVie’s Humira. The rival product made $2.27 billion in the same quarter.
The drug’s EU label is limited to patients taking a combination of an inhaled corticosteroid, long-acting beta2-agonist and long-acting muscarinic antagonist, or a combination of the latter two if they’re not eligible for all three.
Patients on triple therapy made up most of those enrolled in the COPD Phase 3 studies. In the BOREAS and NOTUS trials, the IL‐4Rα agonist reduced the annualized rate of moderate or severe COPD exacerbations by 30% and 34%, respectively.
Last week, Verona Pharma won US approval for Ohtuvayre as a maintenance treatment for COPD. The drug is a first-in-class dual inhibitor of PDE3 and PDE4.