New medicine for pediatric psoriasis! Novartis Cosentyx (Can Be Tsing) has been approved by the European Union: treatment of patients with moderate to severe plaque psoriasis patients aged 6-18 years!

!--webeditor:page title"--August 03, 2020 /PRNewswire/ -- Novartis recently announced that the European Commission (EC) has approved the anti-inflammatory drug Cosentyx (Chinese commodity name: good, generic name: secukinab, Cukchiuu singumantis, commonly known as "sukin monoanti-" ) for children and adolescents under 6 to 18 years of severe severe smudge.
medication, the recommended dose for children weighing 50 kg is 75 mg (no lower weight limit) and the recommended dose for children with a weight of 50 kg is 150 mg (starting at 150 mg, which can be increased to 300 mg if required).
children with psoriasis have a worse quality of life than their peers due to symptoms such as itching and fatigue.
these in turn affect their emotional health and performance at school.
With this approval, Cosentyx will provide a first-line system of therapies for children with psoriasis in Europe.
, Cosentyx has now been approved for four indications, and Novartis plans to expand to 10 in the next decade. Todd Fox, head of immunology, liver and dermatology at Novartis International
, said: "Psoriasis affects children as much as the skin and can lead to a deterioration in quality of life, which can have a lasting impact on this vulnerable patient population.
in the European Union, the approval is the second this year for Cosentyx, which has approved four indications in adults.
we are committed to reimagining the care of children and adults.
" the approval was based on two phase III international studies of children and adolescents aged 6-18: an open-label, arms, parallel group, multicenter moderate to severe plaque psoriasis study, and a randomized, double-blind, placebo- and enacept-controlled study of severe plaque psoriasis.
these 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 weeks.
in 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 week.
in 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 week 52.
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 psoriasis cases begin in childhood, with the most common incidence occurring during adolescence.
moderate to severe psoriasis affects more than 350,000 children worldwide and may have a "more profound than skin" impact on children, with the physical and psychological burden of psoriasis disrupting important growth.
the incidence of psoriasis in children in the United States more than doubled between 1970 and 2000, and the incidence of psoriasis is on the rise in several countries.
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 variety of autoimmune diseases, including psoriasis arthritis (PsA), plaque-type psoriasis (PsO), aggressive spina bifida (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 (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 encephalitis (AS) in china.
mid-June, Cosentyx (®) was approved in China ®.
as a good ® pre-filled injection needle upgrade version, can be good ® feel at will be easy to pen® 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 photo-dified severe plaque psoriasis patients and patients with severe spinal attack to bring more convenient, safe and efficient treatment of new experience.
(!--/ewebeditor: !--ewebeditor: !--." - Sineos Cosentyx® receivings EU for the first-no-first-line systemic treatment in psoriasis !--/ewebeditor.com.