ACPM 269th meeting recommendations, 8-9 April 2010

The resolutions for approval of medicines by the ACPM are recommendations for further action by the TGA and do not constitute approvals in their own right.

THERAPEUTIC GOODS ACT 1989

ADVISORY COMMITTEE ON PRESCRIPTION MEDICINES

RECOMMENDATIONS

The 269th (2010/2) meeting of the Advisory Committee on Prescription Medicines (8th & 9th April 2010) 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 9400

1. ACPM recommends approval of the submission from Orphan Australia Pty Ltd to register a new dose form of mesalazine 1 g (SALOFALK) suppositories for the indication:
   • The treatment of ulcerative proctitis.

RESOLUTION 9401

1. The ACPM recommends approval of the submission from Novartis Pharmaceuticals Pty Ltd to register a new dose form of artemether and lumefatrin (RIAMET/COARTEM) dispersible tablets 20 mg / 120 mg for the indication:
   • RIAMET (COARTEM) is indicated for the treatment of acute, uncomplicated malaria due to Plasmodium falciparum, or mixed infections including P. Falciparum, acquired in areas where parasites may be resistant to other antimalarials

RESOLUTION 9402

1. The ACPM recommends approval of the submission from GE Healthcare Pty Limited to extend the indication for iodixanol (VISIPAQUE) solution for injections 270 mg I / mL and 320mg I / mL to include the indication:
   • VISIPAGUE is indicated in children for:
     • cardioangiography, urography, CT-enhancement and studies of the upper gastrointestinal tract.

RESOLUTION 9403

1. The ACPM recommends approval of the submission from Genzyme Australasia Pty Ltd to register a new chemical entity plerixafor (MOZOBIL) solution for injection 20 mg / mL for the indication:
   • MOZOBIL is indicated in combination with granulocyte colony stimulating factor (GCSF) to mobilise haematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma.

RESOLUTION 9504

1. The ACPM recommends approval of the submission from Pfizer Australia Pty Ltd to extend the indication for celecoxib (CELEBREX) capsules 100 mg, 200 mg and 400 mg to include the indication:
   • Short-term treatment of acute pain in adults following surgery or musculoskeletal and/ or soft tissue injury

RESOLUTION 9405

1. ACPM recommends approval of the submission from Shire Australia Pty Ltd to register a new chemical entity icatibant (as acetate) (FIRAZYR) solution for injection pre-filled syringe 30 mg/ 3 mL for the indication:
   • FIRAZYR is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults (with C1-esterase-inhibitor deficiency).

RESOLUTION 9406

1. The ACPM recommends approval of the submission from Gilead Sciences Pty Ltd to extend the indication for Adefovir dipvoxil (HEPSERA) tablets 10 mg to include the indication:
   • HEPSERA is indicated for the treatment of chronic hepatitis B in patients 12 years of age or older adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
   • This indication is based on histological, virological, biochemical, and serological responses in adult patients with HBeAg+ and HBeAg-/HBV DNA+ chronic hepatitis B with compensated liver function, and in adults patients with clinical evidence of lamivudine-resistant hepatitis B virus with either compensated or decompensated liver function.
   • For adolescent patients (12 to <18 years of age), the indication is based on virological and biochemical responses in patients with HBeAg+ chronic hepatitis B virus with compensated liver function

RESOLUTION 9407

1. The ACPM recommends approval of the submission from Novo Nordisk Pharmaceuticals Pty Ltd to register the new chemical entity liraglutide (VICTOZA) solution for injections 1.2 mg  / 3 mL and 1. 8mg / 3 mL for the indication:
   • VICTOZA is indicated as an adjunct to diet and exercixe for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control
     • in dual combination, added to metformin or a sulphonylurea, in patients with insufficient glycaemic control despite the use of maximally tolerated or clinically adequate doses of metformin or sulphonylurea monotherapy.
     • in triple combination, added to metformin and a sulphonylurea in patients with insufficient glycaemic control despite dual therapy.

RESOLUTION 9408

1. The ACPM recommends approval of the submission from GlaxoSmithKline Australia Pty Ltd to register a new chemical entity pazopanib hydrochloride (VOTRIENT) tablets 200 mg and 400 mg for the indication:
   • Treatment of advanced and/or metastatic renal cell carcinoma (RCC)

RESOLUTION 9409

1. The ACPM recommends approval of the submission from Schering-Plough Pty Limited to register a new fixed dose combination of olmesartan medoxomil and amlodipine (as besylate) (SEVIKAR 20/5, 20/10, 40/5 and 40/10) tablets 20 mg / 5 mg, 20 mg / 10 mg, 40 mg / 5 mg and 40 mg / 10mg for the indication:
   • Treatment of hypertension.
   • Treatment should not be initiated with this fixed-dose combination.

RESOLUTION 9410

1. The ACPM recommends approval of the submission from GlaxoSmithKline Australia Pty Ltd to register the new chemical entity eltrombopag olamine (REVOLADE) tablets 25 mg and 50 mg for the indication:
   • Treatment of adult patients with chronic immune (idiopathic) thrombocytopaenic purpura (ITP) who have had an inadequate response or are intolerant to corticosteroids and immunoglobulins.

RESOLUTION 9411

1. The ACPM recommends approval of the submission from GlaxoSmithKline Australia Pty Ltd to register a new fomulation and change to dosage regimen for pandemic influenza vaccine (H1N1) split virion, inactivated, ASO3 adjuvanted (PANDEMRIX H1N1) suspension in vial and emulsion 3.75 µg Haemagglutinin of A/California/7/2009 like strain per 0.5 mL in 2.5 mL for the indication:
   • PANDEMRIX H1N1 is indicated for prophylaxis of influenza in an officially declared pandemic situation. PANDEMRIX should be used in accordance with official recommendations.

RESOLUTION 9412

1. The ACPM recommends approval of the submission from Commercial Eyes Pty Ltd to register a new chemical entity meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccine (MENVEO) powder and solvent solution for injection containing 10 µg of MenA oligosaccharide and 5 µg of MenC, MenW and MenY oligosaccharides / 0. 5 mL for the indication:
   • MENVEO is indicated for active immunisation of adolescents (from 11 years of age) and adults to prevent invasive disease caused by Neisseria meningitidis serogroups A, C, W-135 and . The use of this vaccine should be in accordance with official recommendations.

RESOLUTION 9413

1. The ACPM recommends approval of the submission from Allergan Australia Pty Limited to register the new strength and formulation for brimonidine tartrate (ENIDIN P /ALPHAGAN P) eye drops 1.5 mg / mL for the indication:
   • <TRADE NAME> eye drops are effective in lowering elevated intraocular (IOP) in patients with chronic open angle glaucoma or ocular hypertension.
   • <TRADE NAME> eye drops can be used in the treatment of glaucoma either as a monotherapy or in combination with topical beta-blockers.

RESOLUTION 9415

1. The ACPM recommends approval of the submission from Bayer Australia Ltd to register the new chemical entity of Dienogest (VISANNE) tablet 2 mg for the indication:
   • Treatment of endometriosis

RESOLUTION 9416

1. The ACPM recommends approval of the submission from GlaxoSmithKline Australia Pty Ltd to extend the indication for lapatinib (as ditosylate monohydrate) (TYBERB) tablet 250 mg to include the indication:
   • Lapatinib (TYKERB) in combination with an aromatase inhibitor is indicated for the treatment of post-menopausal women with hormone receptor-positive metastatic breast cancer whose tumours overexpress HER2 (ErbB2) and for whom hormonal therapy is indicated.

RESOLUTION 9417

1. The ACPM recommends approval of the submission from Roche Products Pty Ltd to extend the indications for Rituximab (MABTHERA) solution for injections 100mg/10 mL and 500mg/ 50mL to include the indication:
   • MABTHERA (rituximab) in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (TNF) inhibitor therapy.
   • Mabthera has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate.

Advisory Committee on Prescription Medicines
16 April 2010

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