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Date: 2016-12-15

Type of information: Submission of a Market Application in the US

Product name: Stelara®

Compound: ustekinumab

Therapeutic area: Autoimmune diseases - Dermatological diseases

Action mechanism:

monoclonal antibody. Stelara® is a human interleukin (IL)-12 and IL-23 antagonist. IL-12 and IL-23 are naturally occurring proteins that are believed to play a role in immune-mediated inflammatory diseases, including psoriasis and psoriatic arthritis.

Company: Janssen-Cilag International, a J&J company (USA - NJ)

Disease:

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

Latest news:

* On December 15, 2016, Janssen Biotech announced the submission of a Supplemental Biologics License Application (sBLA) to the FDA seeking approval of Stelara® (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. Stelara® has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.
This application is supported by data from the Phase 3 CADMUS registration study, which evaluated the efficacy and safety of Stelara® in the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. Results from the CADMUS study have been previously published in the Journal of the American Academy of Dermatology in May 2015. The efficacy and safety profile of Stelara® in the CADMUS trial was consistent with the profile of this anti-IL-12/23 monoclonal antibody as previously observed in adult patients receiving Stelara®. A Phase 3 study, CADMUS Jr, is currently ongoing to evaluate the efficacy and safety of Stelara® in the treatment of pediatric patients 6 to 11 years of age living with moderate to severe plaque psoriasis.

* On May 22, 2015, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval for the use of Stelara® (ustekinumab), for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. The CHMP adopted the opinion based on a review of data from the CADMUS study, which is a Phase 3, randomised, double-blind, placebo-controlled, multicentre trial designed to evaluate the safety and efficacy of Stelara® in patients aged 12 to 17 years with moderate to severe plaque psoriasis. Based on the CHMP's positive opinion, a final decision from the European Commission is expected during the third quarter of 2015. If approved,  Stelara® will become available for the treatment of adolescents from the age of 12 years and older living with moderate to severe plaque psoriasis, a chronic autoimmune disease that affects from 0.5 to 2 per cent of the general population during childhood and adolescence.

* On October 10, 2014, Janssen-Cilag International NV  announced 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. 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. 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].

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization: 2015-06-29

Favourable opinion UE: 2015-05-22

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes