On a roll, Sanofi and Regeneron's Dupixent scores again in second COPD trial

2023-11-27

临床3期临床结果突破性疗法上市批准优先审批

On a roll, Sanofi and Regeneron's Dupixent scores again in second COPD trial

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来源: FiercePharma

Roughly 300,000 people in the United States have the potentially fatal lung condition COPD with type 2 inflammation. By acing a second phase 3 trial, Regeneron and Sanofi's Dupixent is set up to become the first biologic to treat the condition.

Sanofi and Regeneron’s Dupixent has scored in a second phase 3 study in chronic obstructive pulmonary disease (COPD), setting up the monoclonal antibody to become the first biologic to treat the lung disease and the first advancement in the indication in more than a decade.

An approval in COPD would open Dupixent to another huge market. As a treatment for asthma, atopic dermatitis and several other inflammatory conditions, Dupixent already is on a juggernaut trajectory, raking in $3.1 billion in the third quarter, which was a 33% increase year over year. The third-quarter haul brought the drug's sales for the first nine months to $8.4 billion.

Results from the NOTUS study showed that patients on Dupixent, compared to those on placebo, experienced a 34% reduction in COPD exacerbations that needed additional treatment. The treatment also produced significant lung function improvement within 12 weeks, which sustained through 52 weeks.

“These results were from an interim analysis and, given the overwhelmingly positive efficacy of the primary endpoint, will be considered the primary analysis of the trial,” Sanofi and Regeneron said in a release.

The companies plan to submit the data, along with results from the phase 3 BOREAS trial, to the FDA by the end of this year.

Results from BOREAS were presented earlier this year, showing a 30% reduction in exacerbations. The study included 939 COPD patients with type 2 inflammation who were active or former smokers on maximal standard-of-care inhaled therapy and achieved its primary and secondary objectives. The FDA granted breakthrough therapy designation for Dupixent in COPD based on data from the trial.

The European Medicines Agency already is reviewing Dupixent as a treatment for patients with uncontrolled COPD with type 2 inflammation. In the United States, there are approximately 300,000 people with COPD and type 2 inflammation.

Sanofi and Regeneron are investigating another COPD candidate, itepekimab, for former smokers, which make up roughly 70% of the disease population. Itepekimab is due for a readout in 2025, according to Naimish Patel, M.D., Sanofi’s head of global development, immunology and inflammation. The drug is an IL-33 inhibitor IL-33 inhibitor, while Dupixent inhibits the IL-4 and IL-13 pathways.

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