The US Food and Drug Administration (FDA) has granted approval for Novartis’ Cosentyx (secukinumab) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS).
A fully human biologic, Cosentyx hinders interleukin-17A (IL-17A), a cytokine associated with inflammation in HS patients.
The approved dosage for HS is 300mg Cosentyx every four weeks. It can subsequently be given every two weeks, based on the patient’s responses.
The latest development was based on assessments from the Phase III programme in HS, SUNSHINE and SUNRISE.
Findings showed that a greater number of HS patients who received 300mg Cosentyx every two weeks or four weeks attained a hidradenitis suppurativa clinical response versus placebo.
The therapy’s action was found to begin as early as week two, with efficacy gradually rising to week 16 and continuing until week 52.
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Cosentyx’s safety profile was in line with the previously reported safety profile in plaque psoriasis trials.
Novartis US president Victor Bultó said: “Cosentyx can offer effective, lasting relief from HS symptoms so that people with HS have a chance to live every day with confidence.
“With this sixth indication approval for Cosentyx – along with ongoing studies in numerous other conditions – we are re-affirming our commitment to re-imagine medicine for those living with immunological diseases.”
In October 2023, the company spun off its generics and biosimilars business, Sandoz.
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