Novartis Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Cosentyx (secukinumab) for Hidradenitis Suppurativa
- The EMA’s CHMP has adopted a positive opinion recommending marketing authorization of Cosentyx. The opinion was based on the P-III trials (SUNSHINE) & (SUNRISE) evaluating Cosentyx (300mg, q2w/q4w) vs PBO in 545 & 544 patients across 40 countries
- In both trials, patients treated with Cosentyx (300mg, q2w) achieved HiSCR (45.0% vs 33.7%) & (42.3% vs 31.2%) @16wks.; (46.1% vs 31.2%) & (41.8% vs 33.7%) with Cosentyx (300mg, q4w). Treatment response rates continued to improve beyond the 1EPs analysis @16wk.
- ≥55% achieved a HiSCR measure @52wk., ≥50% reduction in pain. The safety results were consistent with the well-established profile of Cosentyx & have been submitted to the US FDA with decisions expected in 2023
Ref: Novartis | Image: Novartis
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