Novartis receives approval in the EU for Cosentyx label update
Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis. The label update includes 52 week data from the CLEAR study demonstrating the long-term superiority of Cosentyx versus Stelara® *(ustekinumab) in psoriasis ,. The updated label also includes use of Cosentyx to treat moderate-to-severe scalp psoriasis - one of the most difficult-to-treat forms of psoriasis, which affects approximately 60 million people worldwide,. The updated label is based on the proven efficacy and consistent safety profile of Cosentyx.
The addition of the CLEAR study data in the European product label reflects the benefit of Cosentyx for people living with this chronic and often distressing condition. The 52 week data show that Cosentyx is superior to Stelara in delivering long-lasting clear or almost clear skin over one year of treatment in adults with moderate-to-severe psoriasis. Cosentyx remained consistently superior to Stelara in achieving and sustaining a PASI 90 response (76% versus 61%) and significantly better in achieving a PASI 100 (clear skin) response (46% versus 36%) at Week 52.
The updated label for Cosentyx on scalp psoriasis, in a difficult-to-treat area of the body, addresses an important unmet need. Many patients with scalp psoriasis do not achieve an adequate response from currently available treatments. Also, scalp psoriasis can be particularly challenging to treat as disease activity is often maintained through hair care, scratching, and shampooing of the scalp, adding to the fact that the application of topical treatments is challenging. Approximately half of all 125 million patients with psoriasis worldwide suffer from scalp psoriasis,.
"We are happy to see these two important label updates for our IL-17A-inhibitor, Cosentyx, the first IL-17A inhibitor approved to treat psoriasis. We are continually investigating new areas for Cosentyx to significantly enhance patients' quality of life, such as scalp psoriasis," said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "Cosentyx is an innovative, groundbreaking treatment for people living with auto-inflammatory diseases, and we're proud to continuously expand treatment possibilities for an even greater number of patients."
Cosentyx is currently the only fully human IL-17A inhibitor to demonstrate efficacy and safety in a dedicated Phase III study of scalp psoriasis. The CHMP approval is based on results from the 24 week study of moderate-to-severe scalp psoriasis where Cosentyx demonstrated superior efficacy compared to placebo. Psoriasis Scalp Severity Index (PSSI) 90 responses were achieved by a significantly greater percentage of patients receiving Cosentyx 300 mg (53%) than placebo (2%) at Week 12 (P<0.001).
The label update is applicable to all European Union and European Economic Area countries. Cosentyx is approved in more than 75 countries for the treatment of moderate-to-severe plaque psoriasis. Cosentyx is also approved in more than 70 countries for the treatment of active PsA and AS.