New drug approvals - September 2024

Active Ingredient (Strength)

Triamcinolone acetonide(40MG/ML)

Application type

NDA-2: New dosage form

Product Registrant

ARCTIC VISION SINGAPORE PTE. LTD.

Date of Approval

19/09/2024

Registration No.

SIN17090P

Indications:
ARCATUS® is indicated for the treatment of macular oedema associated with non-infectious uveitis.

Active Ingredient (Strength)

Bevacizumab(100mg/4ml),
Bevacizumab(400mg/16ml)

Application type

NDA-2: New biosimilar

Product Registrant

INNOGENE KALBIOTECH PTE. LTD.

Date of Approval

25/09/2024

Registration No.

SIN17101P,
SIN17102P

Indications:
Metastatic carcinoma of the colon or rectum(mCRC)
Avamab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.

Metastatic Breast Cancer (mBC)
Avamab in combination with paclitaxel is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer. Avamab in combination with capecitabine is indicated for first-line treatment of patients with HER2-negative metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12months should be excluded from treatment with Avamab in combination with capecitabine. The effective-ness of Avamab in metastatic breast cancer (mBC) is based on an improvement in progression-free survival.Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Avamab in breast cancer.

Non-Small Cell Lung Cancer (NSCLC)
Avamab, in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients withunresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer. Avamab,in combination with erlotinib, is indicated for first-line treatment of patients with unresectable advanced,metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor(EGFR) activating mutations.

Malignant Glioma (WHO Grade IV) – Glioblastoma
Avamab, as a single agent is indicated for the treatment of patients with glioblastoma after relapse ordisease progression following prior therapy. The effectiveness of Avamab in glioblastoma is based on animprovement in objective response rate. There are no data demonstrating an improvement in disease-relat-ed symptoms or increased survival with Avamab.

Advanced and/or metastatic renal Cell Cancer (mRCC)
Avamab in combination with interferon alfa-2a is indicated for first-line treatment of patients with advanced and/or metastatic renal cell cancer.

Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer
Avamab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of advanced(FIGO stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Avamab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel is indicatedfor the treatment of patients with recurrent, platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors. Avamab in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents.

Cervical Cancer
Avamab in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix.

Active Ingredient (Strength)

Enoxaparin Sodium(8,000 IU (80 MG) /0.8 ML),
Enoxaparin Sodium(6,000 IU (60 MG) /0.6 ML),
Enoxaparin Sodium(4,000 IU (40 MG) /0.4 ML),
Enoxaparin Sodium(2,000 IU (20 MG) /0.2 ML)

Application type

NDA-2/3: New biosimilar

Product Registrant

SANDOZ SINGAPORE PTE. LTD.

Date of Approval

11/09/2024

Registration No.

SIN17084P,
SIN17086P,
SIN17085P,
SIN17083P

Indications:
Prophylaxis of venous thromboembolic disease (prevention of blood clot formation in the veins), in particular those which may be associated with orthopedic or general surgery.
Prophylaxis of venous thromboembolic disease in medical patients bedridden due to acute illnesses.
Treatment of established deep vein thrombosis.
Prevention of thrombus formation in extracorporeal circulation during haemodialysis.
Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI), in combination with a thrombolytic agent, in patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI)

Active Ingredient (Strength)

Beclometasone dipropionate(0.200mg/dose),Formoterol fumarate dihydrate(0.006mg/dose),
Beclometasone dipropionate(0.200mg/actuation),Formoterol fumarate dihydrate(0.006mg/actuation)

Application type

NDA-2: New presentation

Product Registrant

ORIENT EUROPHARMA PTE LTD

Date of Approval

25/09/2024

Registration No.

SIN17099P,
SIN17100P

Indications:
Foster Nexthaler is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-actingbeta2-agonist or
- patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.
Foster Nexthaler is indicated in adults.
Note: there are no relevant clinical data on the use of Foster Nexthaler for the treatment of acute asthma attacks.

Active Ingredient (Strength)

Tildrakizumab(100mg/mL)

Application type

NDA-1: New biological entity

Product Registrant

RANBAXY (MALAYSIA) SDN. BHD.

Date of Approval

04/09/2024

Registration No.

SIN17076P

Indications:
Tildrakizumab is an interleukin-23 antagonist indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Active Ingredient (Strength)

ELACESTRANT DIHYDROCHLORIDE eqv ELACESTRANT(345 MG),
ELACESTRANT DIHYDROCHLORIDE eqv ELACESTRANT(86 MG)

Application type

NDA-1/3: New chemical entity

Product Registrant

A. MENARINI SINGAPORE PTE. LTD.

Date of Approval

25/09/2024

Registration No.

SIN17096P,
SIN17097P

Indications:
ORSERDU monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.

Active Ingredient (Strength)

Ustekinumab(90mg/1ml)

Application type

NDA-2: New presentation

Product Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Date of Approval

26/09/2024

Registration No.

SIN17103P

Indications:
Plaque Psoriasis:
STELARA®is indicated for the treatment of adult patients (18 years or older) with moderate tosevere plaque psoriasis who failed to respond to, or who have a contraindication to, or areintolerant to other systemic therapies including cyclosporin, methotrexate or PUVA.
Pediatric Plaque Psoriasis:
STELARA®is indicated for the treatment of pediatric patients (children and adolescents) (6years and older) with moderate to severe plaque psoriasis who are inadequately controlled by, orare intolerant to, other systemic therapies or phototherapies.
Psoriatic Arthritis (PsA):
STELARA®, alone or in combination with methotrexate (MTX), is indicated for:
∙the treatment of adult patients (18 years or older) with active psoriatic arthritis when theresponse to previous non-biological disease-modifying anti-rheumatic drug (DMARD)therapy has been inadequate
∙inhibiting the progression of structural damage
Crohn’s Disease:
STELARA is indicated for the treatment of adults with moderately to severe active Crohn’s disease who have:
∙ failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed treatment with a tumor necrosis factor (TNF) blocker or
∙ failed or were intolerant to treatment with one or more TNF blockers
Ulcerative Colitis:
STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies

Active Ingredient (Strength)

Thiotepa(400mg)

Application type

NDA-2: New presentation

Product Registrant

AXXESSBIO PTE. LTD.

Date of Approval

20/09/2024

Registration No.

SIN17095P

Indications:

TEPADINA is indicated, in combination with other chemotherapy medicinal products:

• with or without total body irradiation (TBI), as conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases in adult and paediatric patients;

• when high dose chemotherapy with HPCT support is appropriate for the treatment of breast cancer in adult patients and CNS tumours in paediatric patients.

Active Ingredient (Strength)

Tislelizumab(100mg/10mL )

Application type

NDA-1: New biological entity

Product Registrant

BEIGENE SINGAPORE PTE. LTD.

Date of Approval

19/09/2024

Registration No.

SIN17089P

Indications:
Non-small cell lung cancer (NSCLC)

TEVIMBRA in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have:
∙ locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or
∙ metastatic NSCLC.

TEVIMBRA in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous NSCLC who have:
∙ locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or
∙ metastatic NSCLC.

TEVIMBRA as monotherapy is indicated for the treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy.

Esophageal squamous cell carcinoma (ESCC)

TEVIMBRA as monotherapy is indicated for the treatment of patients with unresectable, recurrent, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) after prior chemotherapy.

Active Ingredient (Strength)

(Powder vial) sotatercept(45mg),
(Powder vial) sotatercept(60mg),
Sotatercept(45mg),
Sotatercept(60mg)

Application type

NDA-1/3: New biological entity

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

20/09/2024

Registration No.

SIN17091P,
SIN17092P,
SIN17093P,
SIN17094P

Indications:
WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1; Functional Class [FC] II to III) to increase exercise capacity, improve WHO functional class, and delay disease progression

*Evaluated via Access

Active Ingredient (Strength)

Loncastuximab tesirine(10mg/vial)

Application type

NDA-1: New biological entity

Product Registrant

ORIENT EUROPHARMA PTE LTD

Date of Approval

25/09/2024

Registration No.

SIN17098P

Indications:
ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This indication is approved based on overall response rate [see Clinical Studies (14.1)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).