- Novartis AG (NYSE:NVS) announced the results from two Phase 3 studies (SUNSHINE and SUNRISE) of Cosentyx (secukinumab) in moderate-to-severe hidradenitis suppurativa (HS).
- HS is a chronic, inflammatory skin condition affecting up to one in 100 people worldwide, resulting in painful, disfiguring lesions.
- The data showed that Cosentyx demonstrated rapid and sustained relief from signs and symptoms of HS with a favorable safety profile.
- These Phase 3 data have been submitted to European regulatory authorities and will be submitted to the FDA this year.
- The trials assessed two Cosentyx dose regimens across 16-week (vs. placebo) and 52-week treatment periods.
- Results showed a significantly higher proportion of patients achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) when treated with Cosentyx 300 mg, compared with placebo.
- Cosentyx 300 mg dosed every four weeks (after standard weekly loading doses) was superior to placebo for achieving HiSCR in the SUNRISE study (46.1% vs. 31.2%). However, it did not meet statistical significance in the SUNSHINE study (41.8% vs. 33.7%).
- The data pooled from the two studies showed that the 300 mg dose of Cosentyx was statistically superior to the placebo in reducing skin pain.
- Price Action: NVS shares are up 1.71% at $84.01 during the market session on the last check Monday.
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