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ADEC 267th meeting resolutions, 4-5 December 2009

Australian Drug Evaluation Committee

4 December 2009

Published in the Commonwealth of Australia Gazette, No. GN 3, 27 January 2010

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 267th (2009/6) meeting of the Australian Drug Evaluation Committee (ADEC) (4th -5th December 2009) 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 9349

ADEC recommends partial approval of the submission from Astra Zeneca Pty Ltd to extend the indications for quetiapine fumarate (SEROQUEL / SEROQUEL XR) tablets, immediate release 25 mg, 100 mg, 150 mg, 200 mg & 300 mg and composite pack containing 25 mg, 100 mg, 200 mg; modified release 50 mg, 200 mg, 300 mg & 400 mg. The recommended revised indications and proposed dosage are:

SEROQUEL:

Treatment of schizophrenia in patients aged from 13 to 17 years with a recommended dose of 400 mg daily in divided doses.
Monotherapy treatment of acute mania associated with bipolar 1 disorder in patients aged from 10 to 17 years with a recommended dose of 400 mg daily in divided doses. This may be increased to 600 mg daily in divided doses depending on clinical response.

SEROQUEL XR:

Treatment of generalised anxiety disorder in adults who are intolerant to, or had an inadequate response to alternative drug therapies with a recommended dose of 50 to 150 mg daily.

RESOLUTION 9350

ADEC recommends approval of the submission from Actelion Pharmaceuticals Australia Pty Ltd for the extension of indication for miglustat (ZAVESCA) capsules 100 mg for the indication:

Miglustat (Zavesca) is currently indicated for the progressive neurological manifestations in adult and paediatric patients with Niemann-Pick disease Type C

RESOLUTION 9351

ADEC recommends approval of the application for registration of C1 esterase inhibitor (BERINERT) powder for injection 50 U/Ml for the indication:

Berinert is indicated for the treatment of acute attacks in patients with hereditary angioedema (HAE)

RESOLUTION 9352

ADEC recommends approval of the application for registration of aztreonam lysine (CAYSTON) powder for inhalation 75 mg for the indication:

Control of gram-negative bacteria, particularly P. aeruginosa, in the respiratory tract of patients with cystic fibrosis.

The primary support for this indication is based on two single 28 days course placebo controlled studies. The data to support the sustainability of the observed short term benefit over subsequent courses of treatment are limited (see CLINICAL TRIALS)

RESOLUTION 9353

ADEC recommends approval of the submission from Novartis Pharmaceuticals Pty Ltd for the new fixed-dose combination of aliskiren hemifumarate and hydrochlorothiazide (ENVIAGE HCT / RASILEZ HCT) film-coated tablets 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, & 300 mg/25 mg for the indication:

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

RESOLUTION 9354

ADEC recommends approval of the submission from Boehringer Ingelheim Pty Ltd to extend the indication for telmisartan (MICARDIS / PRITOR) tablet 40 mg & 80 mg for the indication:

Prevention of cardiovascular morbidity and mortality in patients 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage

RESOLUTION 9355

ADEC recommends approval of the submission from Bristol-Myers Squibb Australia Pty Ltd to extend the indications for abatacept (rch) (ORENCIA) powder for IV infusion 250 mg to include the indication:

ORENCIA is indicated for reducing signs and symptoms in paediatric patients 6 years of age and older with moderately to severe active polyarticular juvenile idiopathic arthritis who had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). ORENCIA may be used as monotherapy or concomitantly with methotrexate (MTX)

RESOLUTION 9357

ADEC recommends approval of the submission from Merck Serono Australia Pty Ltd to extend the indications for cetuximab (ERBITUX) solution for injection 50 mg/10 mL, 100 mg/20 mL, 250 mg/50 mL, 500 mg/100 mL to include the indications (underlined):

Treatment of patients with epidermal growth factor receptor (EGFR)-expressing, K-RAS wild-type metastatic colorectal cancer (CRC)

  • -In combination with chemotherapy
  • -As a single agent in patients who have failed or are intolerant to oxaliplatin based therapy and irinotecan-based therapy

Treatment of patients with squamous cell cancer of the head and neck (SCCHN)

  • -In combination with radiation therapy for locally advanced disease
  • -In combination with platinum-based chemotherapy for recurrent and/or metastatic disease

RESOLUTION 9358

ADEC recommends approval of the submission from Roche Products Pty Ltd to extend the indications for bevacizumab (AVASTIN) Injection 100 mg/4 mL & 400 mg/16 mL to include the recommended revised indication:

Avastin(bevacizumab) as a single agent, is indicated for the treatment of patients with Grade IV glioma with relapse or disease progression after standard therapy including chemotherapy

RESOLUTION 9359

ADEC recommends approval of the submission from Roche Products Pty Ltd to extend the indications for rituximab (MABTHERA) injection 100 mg/10 mL & 500 mg/50 mL to include the indication:

MABTHERA is indicated for the treatment of patients with CD20 positive chronic lymphocytic leukaemia in combination with chemotherapy

RESOLUTION 9361

ADEC recommends approval of the submission from Novartis Pharmaceuticals Pty Ltd to change the recommended dose in children for imatinib (as mesylate) (GLIVEC) capsules 50 and 100 mg; tablets 100 and 400 mg. The propose dosage seeks to increase the recommended dose in children with chronic phase chronic myeloid leukaemia from 260 mg/m2 per day to:

340 mg/m2 per day

RESOLUTION 9362

ADEC recommends approval of the application for registration of human prothrombin complex (BERIPLEX P/N) powder for injection 250 IU & 500 IU for the indication:

Treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.

RESOLUTION 9363

ADEC recommends approval of the submission from Pfizer Australia Pty Ltd to change the dosing regimen of Somatropin (GENOTROPIN / GENOTROPIN MINIQ) powder for injections with diluent with preservative in a two compartment cartridge/pre-filled syringe 12mg/mL, 5.0 mg, 1.4mg/0.25mL, 0.8mg/0.25mL, 0.4mg/0.25mL, 0.2mg/0.25mL, 1.0mg/0.25mL, 0.6mg/0.25mL, 1.8mg/0.25mL, 2.0mg/0.25mL, 1.2mg/0.25mL, 1.6mg/0.25mL, 16 IU (5.3mg)/mL. The propose change in dosage seeks to revert to the previously approved dosage regimen:

Children with growth hormone deficiency: 0.175 to 0.245 mg/kg bodyweight per week
Turner syndrome: 03 to 0.35 mg/kg bodyweight per week
Prader-Willi syndrome 0.245 to 0.35 mg/kg bodyweight per week
Chronic renal insufficiency: 03 to 0.35 mg/kg bodyweight per week

The weekly dose should be given in equally divided doses 6 to 7 times per week.

RESOLUTION 9364

ADEC recommends partial approval of the registration of saxagliptin free base (as saxagliptin hydrochloride) (ONGLYZA) tablet 5 mg for the amended indications:

ONGLYZA is indicated in patients with type 2 diabetes mellitus, to improve glycaemic control, in combination with one of metformin, a sulfonylurea, or pioglitazone, as an adjunct to diet and exercise, when the single agent alone does not provide adequate glycaemic control.

ONGLYZA is indicated for use as initial combination therapy with metformin, in patients with type 2 diabetes mellitus, to improve glycaemic control as an adjunct to diet and exercise, when dual saxagliptin and metformin is appropriate (i.e. high initial HbA1c levels and poor prospects for response to monotherapy).

RESOLUTION 9365

ADEC recommends approval of the application for registration of brinzolamide and timolol (AZARGA) eye drops brinzolamide 1% and timolol 0.5% w/v for the revised indication:

Decrease of intraocular pressure (IOP) in patients 18 years and over with open angle glaucoma or ocular hypertension for whom monotherapy with each component provides insufficient IOP reduction.

RESOLUTION 9366

ADEC recommends approval of the application for registration of vildagliptin (GALVUS / XILIARX) tablet 50 mg for the indication:

Treatment of diabetes mellitus type 2 in persons 18 years of age and older, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes with one of metformin, a sulfonylurea or pioglitazone when diet, exercise and the single agent do not result in adequate glycaemic control.

Australian Drug Evaluation Committee

18 January 2010

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