Home Medizin Dupilumab erhält von der FDA vorrangige Prüfung für COPD-Zusatzversorgung

Dupilumab erhält von der FDA vorrangige Prüfung für COPD-Zusatzversorgung

von NFI Redaktion

According to a press release from manufacturer Regeneron, the Food and Drug Administration (FDA) has accepted a priority review application for Dupilumab as an add-on therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD).

If approved, Dupilumab would be the only biological option for COPD and the first new treatment option in approximately 10 years.

Dupilumab works by blocking signal transduction through the interleukin (IL) 4 and IL-13 pathways, and Regeneron’s development program focuses on a population of COPD patients who also suffer from type 2 inflammation.

The supplemental Biologics License Application was based on data from two clinical trials in the company’s Phase 3 COPD research program.

In the studies known as BOREAS and NOTUS, adults with uncontrolled COPD and type 2 inflammation, who were current or former smokers, were randomized to receive 300 mg subcutaneous Dupilumab or placebo every two weeks. Type 2 inflammation was defined as an eosinophil count in the blood of at least 300 cells per microliter.

All patients received standard therapy. The primary endpoint of reducing annual moderate or severe acute COPD exacerbations was 30% and 34% higher in the Dupilumab groups compared to the placebo groups in the two studies, and the significant differences in improvement persisted after 52 weeks.

The safety data were similar to previous studies of Dupilumab for its approved indications. The most common adverse events observed in the two studies in 5% or more of Dupilumab patients compared to placebo patients included back pain, COVID-19, diarrhea, headache, and nasopharyngitis.

The „Priority Review“ status is granted to applications for therapies that can offer significant improvements even though the therapies are still in clinical development. The target action date for the FDA decision is June 27, 2024, and according to the company, applications for approval of Dupilumab for the treatment of COPD in China and Europe are also under review.

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