Stelara seeks EU approval for 12 to 17 year old psoriasis patients.

[Fred]

Janssen the makers of Stelara (ustekinumab) are looking for EU approval to treat 12 to 17 year old psoriasis patients that are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

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Janssen-Cilag International NV (Janssen) announced today that a Type II Variation has been filed with the European Medicines Agency seeking approval of STELARA® (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

There currently are limited options for this population in the European Union. In general, children living with moderate to severe psoriasis must contend with a potentially disfiguring and lifelong disease that can permanently impair psychological development.

"Janssen is committed to the continued development of STELARA, especially in this underserved pediatric population," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "We look forward to collaborating with the European Medicines Agency in working towards providing a new treatment option for dermatologists and pediatric patients 12 years and older who may benefit from STELARA."

The application is supported by data from the Phase 3 CADMUS registration study, which evaluated the efficacy and safety, as well as improvements in quality of life, among adolescents (pediatric patients ages 12 to 17) receiving STELARA compared with patients receiving placebo.

About CADMUS:
CADMUS, a Phase 3, randomized, double-blind, placebo-controlled, parallel, multicenter trial, evaluated the efficacy and safety of STELARA in pediatric patients ages 12 to 17 years with moderate to severe plaque psoriasis. Patients (N=110) had been diagnosed more than six months prior to first study agent administration with a Psoriasis Area Severity Index (PASI) score greater than or equal to 12, a Physician's Global Assessment (PGA) score greater than or equal to 3 and body surface area (BSA) involvement of at least 10 percent. In addition, patients were inadequately controlled with topical therapy or were candidates for systemic/phototherapy.

Patients were randomized 1:1:1 to receive subcutaneous placebo, STELARA standard dosing (SD) [intended to achieve exposures comparable to adults] or STELARA half standard dosing (HSD) [intended to achieve exposures half of those seen in adults]. STELARA dosing tiers were determined by body weight. Patients receiving placebo crossed over to receive STELARA SD or HSD at weeks 12 and 16; all patients continued with maintenance dosing every 12 weeks through week 40. Final efficacy and safety evaluations were made at weeks 52 and 60, respectively. The primary endpoint of the study was a PGA score of cleared (0) or minimal (1) at week 12. Secondary endpoints at week 12 included at least a 75 or 90 percent improvement in psoriatic skin lesions, as measured by PASI 75 or PASI 90, and improvement in quality of life, as measured by the Children's Dermatology Life Quality Index (CDLQI) [patient-reported outcome].

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More about: Stelara (ustekinumab)

[jiml]

Janssen the makers of Stelara (ustekinumab) are looking for EU approval to treat 12 to 17 year old psoriasis patients that are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Quote:

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Janssen-Cilag International NV (Janssen) announced today that a Type II Variation has been filed with the European Medicines Agency seeking approval of STELARA® (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

There currently are limited options for this population in the European Union. In general, children living with moderate to severe psoriasis must contend with a potentially disfiguring and lifelong disease that can permanently impair psychological development.

"Janssen is committed to the continued development of STELARA, especially in this underserved pediatric population," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "We look forward to collaborating with the European Medicines Agency in working towards providing a new treatment option for dermatologists and pediatric patients 12 years and older who may benefit from STELARA."

The application is supported by data from the Phase 3 CADMUS registration study, which evaluated the efficacy and safety, as well as improvements in quality of life, among adolescents (pediatric patients ages 12 to 17) receiving STELARA compared with patients receiving placebo.

About CADMUS:
CADMUS, a Phase 3, randomized, double-blind, placebo-controlled, parallel, multicenter trial, evaluated the efficacy and safety of STELARA in pediatric patients ages 12 to 17 years with moderate to severe plaque psoriasis. Patients (N=110) had been diagnosed more than six months prior to first study agent administration with a Psoriasis Area Severity Index (PASI) score greater than or equal to 12, a Physician's Global Assessment (PGA) score greater than or equal to 3 and body surface area (BSA) involvement of at least 10 percent. In addition, patients were inadequately controlled with topical therapy or were candidates for systemic/phototherapy.

Patients were randomized 1:1:1 to receive subcutaneous placebo, STELARA standard dosing (SD) [intended to achieve exposures comparable to adults] or STELARA half standard dosing (HSD) [intended to achieve exposures half of those seen in adults]. STELARA dosing tiers were determined by body weight. Patients receiving placebo crossed over to receive STELARA SD or HSD at weeks 12 and 16; all patients continued with maintenance dosing every 12 weeks through week 40. Final efficacy and safety evaluations were made at weeks 52 and 60, respectively. The primary endpoint of the study was a PGA score of cleared (0) or minimal (1) at week 12. Secondary endpoints at week 12 included at least a 75 or 90 percent improvement in psoriatic skin lesions, as measured by PASI 75 or PASI 90, and improvement in quality of life, as measured by the Children's Dermatology Life Quality Index (CDLQI) [patient-reported outcome].

Source: NO LINKS ALLOWED

More about: Stelara (ustekinumab)

What great news for youngsters. We regularly hear of the currently available treatment being ineffective or limited effectiveness
If this does go through it will be a great relief to many young children/ adults who are at a very vulnerable stage in life
If it helps a few to rid themselves of the visible effect of psoriasis for a while that's great news and will,lift their self esteem and self confidence..... If only it was around when I was a youngster.......... These are indeed exciting times for sufferers, with many new drugs in the pipeline and if they can get them accepted for youngsters it will make life more tolerable for them

[Fred]

What great news for youngsters. We regularly hear of the currently available treatment being ineffective or limited effectiveness
If this does go through it will be a great relief to many young children/ adults who are at a very vulnerable stage in life
If it helps a few to rid themselves of the visible effect of psoriasis for a while that's great news and will,lift their self esteem and self confidence..... If only it was around when I was a youngster.......... These are indeed exciting times for sufferers, with many new drugs in the pipeline and if they can get them accepted for youngsters it will make life more tolerable for them

It is good news Jim, and news that may encourage some adults to give Stelara a try. If it can be used on young people then that speaks volumes for it's safety and efficacy.

And you're right these are good times for people both young and old with psoriasis, as there are many more treatments in the pipeline. Plus the new treatments are going through strict tests and proving to be effective.