Phase III data showed Cosentyx can provide rapid relief from symptoms of hidradenitis suppurativa as early as Week 2
The US Food and Drug Administration (FDA) has approved the Novartis drug, Cosentyx, (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults.
HS is a chronic, progressive and painful disease which affects one in 100 people worldwide, and has limited treatment options.
“Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation of HS,” said the Swiss company.
The FDA approval was based on robust Phase III data (SUNSHINE and SUNRISE studies) in which Cosentyx showed rapid relief from HS symptoms as early as Week 2.
If the HS patient shows an inadequate response, a 300 mg dose of Cosentyx will be administered every four weeks or every two weeks.
Novartis president, Victor Bulto said: “Cosentyx can offer effective, lasting relief from HS symptoms so that people with HS have a chance to live every day with confidence.”
Hidradenitis suppurativa (HS) causes recurring boil-like lumps that may burst into open wounds, leading to irreversible scarring.
The skin disease is commonly seen in the most intimate parts of the body.
It is often diagnosed late (may take up to 10 years), which results in disease progression and significantly impact the patient’s quality of life.
Commenting on the drug’s approval, Donna Atherton, EdD, Founder and Chief Mission Officer, International Association of Hidradenitis Suppurativa Network (IAHSN), said: “HS is one of the most devastating and exhausting skin diseases.”
“The approval of a new treatment option brings fresh hope to me and the HS community that we may find relief from the burden of the disease,” she added.
Cosentyx is the second biologic approved to treat HS patients.