New medicine for pediatric psoriasis! Novartis Cosentyx (Can Be Good) EU will soon be approved: treatment of patients with moderate to severe plaque psoriasis patients aged 6-18 years!

, 27 June 2020 /

BIOON/
Novartis
announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued a positive review recommending approval for anti-inflammatory The drug Cosentyx (Chinese commodity name: good, universal name: secukinumab, Cucciu sepsis, commonly known as "Sukin sings), for moderate to severe plaque psoriasis in children and adolescents (6 to 18 years of age)now, CHMP's comments will now be referred to the European Commission, which is expected to make a final review decision within the next two monthsIf approved, Cosentyx will provide a first-line system of treatment for children with psoriasisCurrently, Cosentyx has approved four indications, and Novartis plans to expand to 10 in the next decade"Psoriasis affect
s children as much as the skin and can lead to a deterioration in quality of life, potentially having a lasting impact on this vulnerable group of patients," said Todd Fox, director
of immunology, liver and dermatology at NovartisInternational Medical Affairs,Following the recent approval of the nr-axSpA apparel side in the EU, the CHMP review is the second positive CHMP opinion given to Cosentyx so far this yearThe latest positive comments are an important step in our commitment to reimagine the care of children with psoriasis so that they can enjoy a full and active life freely"
CHMP's positive opinion is based on two Phase III international studies of children and adolescents aged 6-18: an open-label, bi-arms, parallel group, multicenter moderate to severe plaque psoriasis study, and a randomized, double-blind, placebo, and enacept-controlled study of severe plaque psoriasisThese studies show that low-dose (75-150 mg) and high-dose (75-300 mg) Cosentyx are very effective in rapidly improving skin symptoms and quality of life, with good safety over a period of 52 weeksin children with moderate to severe plaque psoriasis, low doses of Cosentyx have fast, strong skin plaque removal: 93% of patients reach PASI 75 relief at the 12th week of treatment (75% improvement in psoriasis area and severity index compared to baseline), 69% of patients reach PA by 12 weeks SI 90 remission (improved by 90%), 88% of patients reached PASI 90 at the 24th week, in addition, 59.5% of patients reached the total removal of skin loss at the 12th week (PASI 100), and 67% of patients reached PASI 100 at the 24th weekIn patients with severe psoriasis, low doses of Cosentyx ensured continuous skin loss removal until the 52nd week, with 75% of patients reaching PASI 90 relief Severe psoriasis patients as early as the 4th week, moderate to severe psoriasis patients as early as the 2nd week showed differences in PASI 75 According to the Children's Skin Disease Quality of Life Index (CDLQI) 0/1 response, half of the children with moderate to severe plaque psoriasis were completely relieved by the symptom burden of psoriasis by 12 weeks In children with severe plaque type psoriasis treated with low doses of Cosentyx, 44.7% of patients were completely remissioned at the 12th week and 60.6% were completely remissioned at the 52st week Low-dose and high-dose Cosentyx safety characteristics are similar and consistent with established adult psoriasis indications No new safety signals were observed in children psoriasis is a systemic inflammatory disease that seriously affects the physical and emotional quality of life of patients One third of cases of psoriasis occur in childhood, with the most common incidence occurring during adolescence Moderate and severe psoriasis affects more than 350,000 children worldwide and can have a "more profound than skin" impact on children, with the physical and psychological burden of psoriasis disrupting important growth Between 1970 and 2000, the incidence of psoriasis in children in the United States more than doubled, and the incidence of psoriasis in several countries increased Only a few approved treatment options are available, and unmet medical needs remain high Cosentyx is the first human monoclonal antibody drug specifically targeted to inhibit leukerin-17A (IL-17A), selectively targeting the activity of the circulating IL-17A, reducing immune system activity and improving disease symptoms Studies have revealed that IL-17A plays an important role in driving the body's immune response to a wide range of autoimmune diseases, including psoriasis arthritis (PsA), plaque psycosis (PsO), aggressive spina encephalitis (AS), and radiological-negative mid-axis spinal arthritis (nr-axSpA) Cosentyx was approved for listing in January 2015 and has now been approved for four indications (PsO, PsA, AS, nr-axSpA) Cosentyx has strong clinical evidence to support, including five-year data on the top three adaptations (PsO, PsA, AS), as well as data from real-world evidence These data reinforce Cosentyx's unique position as a rapid and long-lasting combination of treatments across axSpA, PsA and psoriasis More than 340,000 patients worldwide have been treated with Cosentyx since it went on the market in China, Cosentyx (®) was approved by the State Drug Administration (NMPA) at the end of April for routine treatment of adult patients with ineffective severe scoliosis (AS) This is the second indication that can be approved in China following the approval of the ® in March 2019 for the treatment of moderate to severe plaque psyritus (PsO), and the first and only interlemic inhibitor approved for the treatment of aggressive spina bifida (AS) in the country mid-June, Cosentyx (®) was approved in China ® As a good ® pre-filled injection needle upgrade version, can be good ® feel at ease® will optimize the original way of administration, "one touch" operation to reduce the difficulty of injection, improve the patient's treatment experience, while effectively avoiding the drug waste caused by operational errors, for China's light large and severe plaque psoriasis patients and patients with severe spinal attack to bring more convenient, safe and efficient treatment of new experience (BioValleyBioon.com) original source: Novartis Cosentyx® gains positive CHMP opinion for the psoriasis, rusingsing dweud ei dweud and safety profile .