conventional systemic HS therapy. US 10 November 2014 Approved on 09 September 2015 Humira is indicated for the treatment of moderate to severe hidradenitis suppurativa. Canada 14 January 2015 Approved on 31 December 2015 Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa in patients, who have not responded to conventional therapy (including systemic antibiotics). Product Information The Product Information (PI) approved with the submission which is described in this AusPAR can be found as Attachment 1. For the most recent PI, please refer to the TGA website at <>. II. Quality findings There was no requirement for a quality evaluation in a submission of this type. III. Nonclinical findings There was no requirement for a nonclinical evaluation in a submission of this type. IV. Clinical findings A summary of the clinical findings is presented in this section. Further details of clinical findings can be found in Attachment 2. Clinical rationale Hidradenitis suppurativa (HS) is a debilitating, chronic inflammatory follicular disease characterised by the formation of recurrent abscesses, inflammatory nodules, and fistulas. It mainly involves skin regions with apocrine glands such as axillae, groins, perineal and perianal areas, and submammary areas. Lesions are often painful and result in malodorous discharge. Complications include excessive scarring and fibrosis potentially leading to contractures and limitations in mobility, as well as anal, urethral, and rectal strictures. Other comorbidities associated with HS include anaemia, secondary infection, malignancy (such as non–melanoma skin cancer [NMSC]), depression, and anxiety. These disease sequelae result in significant reduction of health related quality of life in affected individuals. The estimated prevalence of HS is approximately 1%. The disease onset is typically in the second and third decade of life and is rare in prepubertal children. Women are affected more commonly than men (female/male ratio approximately 2:1). Predisposing factors include obesity and cigarette smoking. The diagnosis is usually established based on the
For the missing information related to safety information in the treatment of children < 6 years of age for pedCD, and long term safety information in the treatment of children aged 6 years to < 18 years with pedERA’, Table 3: ‘Overview of Ongoing and Planned Pharmacovigilance Actions’ of the ASA should be amended to include details of Study M11328 to be consistent with Table 100: ‘Required Additional Pharmacovigilance Activities’ of the EU–RMP. The sponsor states: “AbbVie would like to point out that this information has been captured in version 4.0 of the ASA, which was submitted recently in PM–2015–01149–1–3. Please refer to Table 3, Overview of Ongoing and Planned Pharmacovigilance Actions, on page 46 (of 79)”. This is acceptable. For clarity and as per the ASA template, as found on the TGA website as of 4 May 2015, the sponsor should include a table briefly summarising the pharmacovigilance and risk minimisation activities proposed for Australia in a revised ASA. The sponsor states: ‘AbbVie would like to point out that this information has been captured in version 4.0 of the ASA, which was submitted recently in Please refer to Table 5, Summary of the Risk Minimisation Plan in Australia, on pages 58 –68 (of 79)’. In the instance Table 5 should be renamed and corrected to ‘Summary of the Risk Management Plan in Australia’. Secondly it is apparent that the specified missing information in Table 4: ‘Summary of the Risk Minimisation Plan in Australia’ and Table 5 of the updated ASA has been significantly rationalised, including the deletion of ‘Subjects with renal or liver impairment’, compared to what was previously accepted for Humira. It would appear the only justification offered for such change was ‘Missing information was updated’, which is considered to be inadequate. Consequently the sponsor should provide compelling justification for apparent changes to the missing information items previously accepted for Humira or alternatively reinstate these safety concerns, which need only be reflected in a revised ASA preferably before this application is approved.