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New drug indication approval - Mar 2021

Product Name	VENCLEXTA FILM COATED TABLET 10MG, 50MG AND 100MG
Active Ingredient	Venetoclax
Product Registrant	ABBVIE PTE LTD
Date of Approval	04/03/2021
Indications: Acute Myeloid Leukemia VENCLEXTA is indicated, in combination with a hypomethylating agent or in combination with low-dose cytarabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy [see CLINICAL STUDIES/USE IN SPECIFIC POPULATIONS].

Product Name	ABILIFY TABLET 5 MG, 10 MG, 15 MG
Active Ingredient	Aripiprazole
Product Registrant	OTSUKA PHARMACEUTICALS (SINGAPORE) PTE. LTD.
Date of Approval	10/03/2021
Indications: Schizophrenia ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY in the treatment of schizophrenia was established in four short-term (4- and 6-week) controlled trials in adults and one 6-week trial in paediatrics (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to paediatrics [see CLINICAL STUDIES (13.1)]. The physician who elects to use ABILIFY for extended periods should periodically re-evaluate the long- term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION (2)]. Bipolar I Disorder ABILIFY is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder and for maintaining stability or preventing recurrence, as monotherapy in adults and in adolescents aged 13 years and older, and as an adjunct to lithium or valproate in adults. The efficacy of ABILIFY as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in paediatric patients. Efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults [see CLINICAL STUDIES (13.2)]. Maintenance efficacy was demonstrated in one monotherapy maintenance trial and in one adjunctive maintenance trial in adults [see CLINICAL STUDIES (13.2)]. Physicians who elect to use ABILIFY for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see DOSAGE AND ADMINISTRATION (2)]. Irritability Associated with Autistic Disorder ABILIFY is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in paediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) [see CLINICAL STUDIES (13.4)]. The efficacy of ABILIFY for the maintenance treatment of irritability associated with autistic disorder was not established. Tourette’s Disorder ABILIFY is indicated for the treatment of Tourette’s disorder. Efficacy was established in one 8-week (aged 7 to 17 years) and one 10-week (aged 6 to 18 years) placebo-controlled trial in paediatric patients with Tourette’s disorder [see CLINICAL STUDIES (13.5)].

Product Name	Alunbrig Initiation Pack, Alunbrig Film-Coated Tablet 180mg, 90mg and 30mg
Active Ingredient	Brigatinib
Product Registrant	Takeda Pharmaceuticals (Asia Pacific) Pte. Ltd.
Date of Approval	11/03/2021
Indications: ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. ALUNBRIG is indicated for the treatment of adult patients with ALK-positive advanced NSCLC previously treated with crizotinib.

Product Name	TECENTRIQ CONCENTRATE FOR SOLUTION FOR INFUSION 1200 MG/20 ML AND 840 MG/14 ML
Active Ingredient	Atezolizumab
Product Registrant	ROCHE SINGAPORE PTE. LTD.
Date of Approval	11/03/2021
Indications: Tecentriq as monotherapy is indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have a PD-L1 expression ≥ 50% tumor cells (TC) or ≥ 10% tumor-infiltrating immune cells (IC) and who do not have EGFR or ALK genomic tumor aberrations.

Product Name	DUPIXENT SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 300 mg/2ml
Active Ingredient	Dupilumab
Product Registrant	SANOFI-AVENTIS SINGAPORE PTE. LTD.
Date of Approval	15 Mar 2021
Indications: DUPIXENT is indicated for the following diseases: 1.1 Atopic Dermatitis DUPIXENT is indicated for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis who require chronic treatment and whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. 1.2 Asthma DUPIXENT is indicated in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by elevated blood eosinophils and/or elevated FeNO. DUPIXENT is indicated as maintenance therapy for oral corticosteroid-dependent asthma.

Product Name	TRULICITY INJECTION 1.5 MG/0.5 ML AND 0.75 MG/0.5 ML
Active Ingredient	Dulaglutide
Product Registrant	DKSH SINGAPORE PTE. LTD.
Date of Approval	16/03/2021
Indications: Type 2 Diabetes Mellitus Trulicity is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.

Product Name	TREMFYA SOLUTION FOR INJECTION IN PRE-FILLED PEN 100 MG/ML
Active Ingredient	Guselkumab
Product Registrant	Johnson & Johnson Pte. Ltd.
Date of Approval	18/03/2021
Indications: Psoriatic arthritis TREMFYA® is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.

Product Name	MYFORTIC GASTRO-RESISTANT TABLET 180 MG, 360 MG
Active Ingredient	Mycophenolate sodium
Product Registrant	NOVARTIS (SINGAPORE) PTE LTD
Date of Approval	22/03/2021
Indications: Myfortic is indicated for induction and maintenance treatment of adult patients with ISN/RPS Class III, IV or V lupus nephritis. The evidence for efficacy was based on surrogate endpoints in studies where the majority of patients with lupus nephritis were ISN/RPS (2003) Class IV (see Clinical Studies section).

Product Name	LYNPARZA FILM COATED TABLETS 100MG, 150MG
Active Ingredient	Olaparib
Product Registrant	AstraZeneca Singapore Pte Ltd
Date of Approval	29/03/2021
Indications: Lynparza is indicated as monotherapy for the: Treatment of adult patients with metastatic castration-resistant prostate cancer and homologous recombination repair gene BRCA1/2 and/or ataxia telangiectasia (ATM)-mutations (germline and/or somatic) who have progressed following a prior new hormonal agent.

Product Name	XELJANZ TABLET 5MG
Active Ingredient	Tofacitinib citrate
Product Registrant	PFIZER PRIVATE LIMITED
Date of Approval	30/03/2021
Indications: Psoriatic Arthritis XELJANZ (tofacitinib) in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy (see Pharmacodynamic properties (Section 5.1)). Ulcerative Colitis XELJANZ (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see Pharmacodynamic properties (Section 5.1)).

Product Name	LONSURF FILM-COATED TABLET 15MG/6.14MG AND 20MG/8.19MG
Active Ingredient	Trifluridine/Tipiracil hydrochloride
Product Registrant	TAIHO PHARMA SINGAPORE PTE. LTD.
Date of Approval	31/03/2021
Indications: 1.2 Metastatic Gastric Cancer Lonsurf® is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma who have been previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

Healthcare professional, Industry member, Therapeutic Products

Published: 31 Mar 2021

New Drug Indication Approvals