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ADEC 255th meeting resolutions, 6-7 December 2007

Australian Drug Evaluation Committee

6 December 2007

Published in the Commonwealth of Australia Gazette, No. GN 4, 30 January 2008

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 255th (2007/6) meeting of the Australian Drug Evaluation Committee (ADEC) (6-7 December 2007) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medicines should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

RESOLUTION 9123

There should be no objection to approval of the submission from Eli Lilly Australia Pty Ltd to register two new strengths and a new dosage regimen of once daily dosing for CIALIS tablets containing tadalafil 2.5mg and 5mg for the treatment of erectile dysfunction in adult males. CIALIS is not indicated for use by women.

The following once daily dosing regimen should be used "In responder patients to the on demand regimen who anticipate a frequent use of CIALIS (i.e. at least twice weekly) a once daily regimen with the lowest doses of CIALIS might be considered suitable, based on patient choice and the physician's judgement. In these patients the recommended dose is 5mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5mg once a day based on individual tolerability. The appropriateness of continued use of the daily regimen should be reassessed periodically".

RESOLUTION 9124

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to register AVAMYS nasal spray containing fluticasone furoate 27.5 µg per actuation for the indication:

For the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and children aged 2 years and over.

RESOLUTION 9125

There should be no objection to approval of the submission from Roche Products Pty Ltd to register HERCEPTIN powder for injection containing trastuzumab 150 mg for the new indication:

For the treatment of patients with metastatic breast cancer who have tumours that over express HER2:

  • In combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone receptor positive metastatic breast cancer.

RESOLUTION 9126

The submission from GlaxoSmithKline Australia Pty Ltd to register SERETIDE Metered Dose Inhaler containing fluticasone propionate / salmeterol xinaforte 50 µg / 25 µg, 125 µg / 25 µg and 250 µg / 25 µg per actuation and SERETIDE Dry Powder Inhaler (ACCUHALER) containing fluticasone propionate / salmeterol xinaforte 100 µg / 50 µg, 250 µg / 50 µg and 500 µg / 50 µg per actuation for product information (PI) changes to reflect an increased reporting of pneumonia in studies of patients with COPD receiving SERETIDE should be approved.

RESOLUTION 9127

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to register the new strength and new dosage regimen for MESASAL enteric coated tablets containing mesalazine 500 mg for the treatment of ulcerative colitis (active disease and maintenance therapy) in patients sensitive to sulfasalazine.

The dosage regimen should be 500mg tds to 1 g tds (or 1.5g to 3g daily).

RESOLUTION 9128

There should be no objection to approval of the submission from Novo Nordisk Pharmaceuticals Pty Ltd to extend the registered uses of NOVORAPID INSULIN ASPART solution for injection containing insulin aspart(rys) 100 U/mL to include use during pregnancy and use in children aged two years and older in the treatment of diabetes mellitus.

RESOLUTION 9129

There should be no objection to approval of the submission from Novo Nordisk Pharmaceuticals Pty Ltd to register a new dosage regimen for NOVOSEVEN powder for injection containing eptacog alfa (recombinant Factor VIIa) 1.2 mg (60 KIU), 2.4 mg (120 KIU) and 4.8 mg (240 KIU) for the control of bleeding in adult patients with haemophilia who have developed inhibitors to coagulation Factors VIII or IX.

The alternative dosage regimen should be a single dose of 270 µg/kg.

The application for a prophylaxis regimen (90 µg/kg once daily) for the prevention of bleeding episodes should be approved.

RESOLUTION 9130

There should be no objection to approval of the submission from Solvay Biosciences Pty Ltd to register ZAN-EXTRA 10/10 and ZAN-EXTRA 10/20 film coated tablets containing the fixed dose combination of lercanidipine hydrochloride 10 mg with enalapril maleate 10 or 20 mg

For the treatment of hypertension. Treatment should not be initiated with these fixed dose combinations. (See DOSAGE AND ADMINISTRATION).

RESOLUTION 9131

There should be no objection to approval of the submission from Novartis Pharmaceuticals Australia Pty Limited to register EXFORGE fixed combination tablets containing amlodipine (as besylate) and valsartan in the following ratios (5/80mg, 5/160mg and 10/160mg) for the indication:

For the treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.

RESOLUTION 9132

There should be no objection to approval of the submission from Boehringer Ingelheim Pty Ltd to register the new dose form SPIRIVA RESPIMAT or FAVINT RESPIMAT solution for inhalation containing tiotropium (as bromide monohydrate) 2.5 µg per actuation for the indication:

For the long term maintainance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD). SPIRIVA is indicated for the prevention of COPD exacerbations.

RESOLUTION 9133

There should be no objection to approval of the submission from Bayer Schering Pharma to register a new strength and new dosage regimen for YAZ tablets containing the new salt form ethinyloestradiol (as betadex clathrate) 0.02 mg combined with drospirenone 3 mg in 28 active tablets and presented with 4 inactive placebo tablets for the indications:

  • For use as an oral contraceptive.
  • For the treatment of moderate acne vulgaris in women seeking oral contraception.
  • For the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of YAZ for PMDD was not assessed beyond 3 cycles. YAZ was not evaluated for treatment of PMS (premenstrual syndrome) SEE CLINICAL TRIALS.

RESOLUTION 9134

There should be no objection to approval of the submission from Solvay Biosciences Pty Ltd to register the new dose form and new route of administration for DUODOPA intestinal gel containing levodopa 20mg/mL and carbidopa 5mg/mLfor the indication:

For the treatment of advanced idiopathic Parkinson's disease with severe motor fluctuations despite optimised oral treatment. A positive clinical response to DUODOPA administered via a temporary nasoduodenal tube should be confirmed before a permanent percutaneous endoscopic gastrostomy (PEG) tube is inserted.

RESOLUTION 9135

There should be no objection to approval of the submission from Merck Sharp & Dohme (Australia) Pty Ltd to register ISENTRESS tablets containing the new chemical entity raltegravir 400mg for the indication:

  • In combination with other antiretroviral agents for the treatment of HIV- 1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.This indication is based on analyses of plasma HIV-1 RNA levels up through 24 weeks in two controlled studies of ISENTRESS. These studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response [see Clinical Studies (14)]. The safety and efficacy of ISENTRESS have not been established in treatment-naïve adult patients or paediatric patients.There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.
  • The recommended dose of raltegravir in adults is 400 mg twice daily

RESOLUTION 9136

There should be no objection to approval of the submission from Merck Sharp & Dohme (Australia) Pty Ltd to register SINGULAIR tablets and oral granules containing montelukast (as sodium) 4mg or 5mg (chewable tablets) or 10mg (film coated tablets) or 4mg (oral granules) for the new indication:

For symptomatic treatment of seasonal allergic rhinitis.

RESOLUTION 9137

There should be no objection to approval of the submission from Merck Sharp & Dohme (Australia) Pty Ltd to vary the approved Product Information for SINGULAIR tablets and oral granules containing montelukast (as sodium) 4mg or 5mg (chewable tablets) or 10mg (film coated tablets) or 4mg (oral granules) to include information regarding the growth effects from the two specific studies, provided the lack of their utility to infer long term effects is made clear. Study 910 may be cited as a safety study.

RESOLUTION 9139

There should be no objection to approval of the submission from Pfizer Australia Pty Ltd to register CELSENTRI tablets containing the new chemical entity maraviroc 150 mg & 300 mg for the indication:

  • In combination with other antiretrovirals, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1. The indication is based on analyses of plasma HIV-1 RNA levels and CD4 counts at 24 weeks in two double-blind, placebo controlled trials of 24 weeks duration in treatment experienced patients with clinically advanced disease resistant to three or four classes of antiretrovirals.
  • The use of other active agents with CELSENTRI is associated with a greater likelihood of treatment response.
  • The recommended dose of maraviroc is 300mg twice daily.

RESOLUTION 9140

There should be no objection to approval of the submission from Novartis Pharmaceuticals Pty Ltd to register TASIGNA capsules (hard) containing the new chemical entity nilotinib 200 mg for the indication:

For the treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive chronic myeloid leukaemia resistant to or intolerant of prior therapy including imatinib.

RESOLUTION 9141

There should be no objection to approval of the submission from Baxter Healthcare Pty Ltd to register KIOVIG solution for injection containing the new biological entity human normal immunoglobulin 10% w/v for the following indications:

  1. Primary Immunodeficiency Disorders (PID) associated with defects in humoral immunity, acting as replacement therapy, including:
    • Congenital agammaglobulinemia and hypogammaglobulinemia
    • Common variable immunodeficiency
    • Severe combined immunodeficiency
    • Wiskott Aldrich syndrome
  2. Secondary immunodeficiency syndromes including:
    • Myeloma (B-cell chronic lymphocytic leukaemia) with severe secondary hypogammaglobulinemia and recurrent infections.
    • Paediatric HIV infection
    • Allogenic bone marrow transplantation
  3. Immunomodulation:
    • Idiopathic thrombocytopenic purpura (ITP), in children or adults at high risk of bleeding prior to surgery to correct the platelet count.
    • Guillain Barre syndrome (GBS)
    • Kawasaki disease