Novartis Cosentyx Receives Positive CHMP Opinion for Treatment of Moderate-to-Severe Plaque Psoriasis in Children and Adolescents Aged 6–18 in the EU

Jun 28, 2020 09:26 CST Updated 01:29

Novartis

Drug Development and Manufacturing

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.

European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.

June 27, 2020 News /BioValleyBIOON/ --Novartis(Novartis) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of the anti-inflammatory drug Cosentyx (Chinese brand name: Kesenting; generic name: secukinumab; commonly known as "Su Jin Dan Kang") for the treatment of pediatric and adolescent patients (aged 6 to under 18 years) with moderate-to-severe plaque psoriasis.

Now, the CHMP’s opinion will be submitted to the European Commission (EC) for review, which is expected to make a final decision within the next two months. If approved, Cosentyx will provide a first-line systemic therapy for pediatric patients with psoriasis. Currently, Cosentyx has been approved for four indications, and Novartis plans to expand this to ten indications over the next decade.

NovartisInternational Medical AffairsImmunologyTodd Fox, Head of Hepatology and Dermatology, stated, “Psoriasis affects children far beyond the skin, leading to a deterioration in quality of life and potentially having lasting impacts on this vulnerable patient population. Following the recent approval of the nr-axSpA indication in the European Union, this CHMP opinion marks the second positive CHMP opinion for Cosentyx this year. This latest positive opinion represents an important step in our commitment to reimagining care for children with psoriasis, enabling them to freely enjoy full and active lives.”

The CHMP’s positive opinion was based on two Phase III international studies in pediatric and adolescent patients aged 6 to 18 years: an open-label, two-arm, parallel-group, multicenter study in moderate-to-severe plaque psoriasis, and a randomized, double-blind, placebo- and etanercept-controlled study in severe plaque psoriasis. These studies demonstrated that both the low dose (75–150 mg) and high dose (75–300 mg) of Cosentyx were highly effective in rapidly improving skin symptoms and quality of life, with a favorable safety profile over up to 52 weeks.

In children with moderate-to-severe plaque psoriasis, low-dose Cosentyx demonstrated rapid and potent clearance of skin plaques: 93% of patients achieved PASI 75 response (a 75% improvement from baseline in the Psoriasis Area and Severity Index) at Week 12, 69% achieved PASI 90 response (90% improvement) at Week 12, and 88% achieved PASI 90 response at Week 24. Furthermore, 59.5% of patients achieved complete skin clearance (PASI 100) at Week 12, and 67% achieved PASI 100 response at Week 24. In patients with severe psoriasis, low-dose Cosentyx ensured sustained skin clearance through Week 52, with 75% of patients achieving PASI 90 response. Differences in PASI 75 response were observed as early as Week 4 in patients with severe psoriasis and as early as Week 2 in those with moderate-to-severe psoriasis.

According to the 0/1 response assessment of the Children’s Dermatology Life Quality Index (CDLQI), half of children with moderate-to-severe plaque psoriasis achieved complete relief from the symptom burden of psoriasis before Week 12. Among children with severe plaque psoriasis treated with low-dose Cosentyx, 44.7% of patients achieved complete clearance at Week 12, and 60.6% at Week 52. The safety profiles of both low-dose and high-dose Cosentyx were similar and consistent with those established for adult psoriasis indications. No new safety signals were observed in the pediatric population.

Psoriasis is a lifelong, systemic inflammatory disease that significantly impairs patients’ physical and emotional quality of life. One-third of psoriasis cases begin in childhood, with onset most commonly occurring during adolescence. Moderate-to-severe psoriasis affects more than 350,000 children worldwide and can have “profound effects beyond the skin,” as the physiological and psychological burden of psoriasis disrupts critical developmental periods. Between 1970 and 2000, the incidence of pediatric psoriasis in the United States more than doubled, and rising incidence trends have been observed in multiple countries. Few approved therapeutic options are available, and unmet medical needs remain high.

Cosentyx is the first fully human monoclonal antibody drug that specifically targets and inhibits interleukin-17A (IL-17A). It selectively blocks the activity of circulating IL-17A, reduces immune system activity, and alleviates disease symptoms. Studies have revealed that IL-17A plays a key role in driving the body’s response in variousAutoimmunityplays an important role in the immune response of spondyloarthropathies, including psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA).

Cosentyx was approved for marketing in January 2015 and has currently received approval for four indications (PsO, PsA, AS, nr-axSpA). Cosentyx is supported by robust clinical evidence, including 5-year data for the top three indications (PsO, PsA, AS) as well as real-world evidence. These data reinforce the unique position of Cosentyx as a rapid, durable, and comprehensive treatment option across axSpA, PsA, and psoriasis. Since its launch, more than 340,000 patients worldwide have been treated with Cosentyx.

In China, Cosentyx® (Secukinumab) received approval from the National Medical Products Administration (NMPA) in late April this year for the treatment of adult patients with ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy. This marks the second indication approved for Cosentyx® in China, following its initial approval in March 2019 for the treatment of moderate-to-severe plaque psoriasis (PsO). It is currently the first and only interleukin inhibitor approved in China for the treatment of ankylosing spondylitis (AS).

In mid-June, Cosentyx® (Secukinumab) Sensoready® Pen was approved in China. As an upgraded version of the Cosentyx® pre-filled syringe, the Cosentyx® Sensoready® Pen comprehensively optimizes the original administration method. Its “one-touch” operation reduces injection difficulty and enhances patient treatment experience, while effectively minimizing drug waste caused by operational errors. This brings a more convenient, safe, and efficient new treatment experience to the vast number of Chinese patients with moderate-to-severe plaque psoriasis and ankylosing spondylitis. (Bioon.com)

Original Source: Novartis Cosentyx® gains positive CHMP opinion for pediatric psoriasis, reinforcing established efficacy and safety profile