New drug indication approval - September 2023

Product Name

COSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 300MG/2ML

COSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 150MG/ML

COSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 75MG/0.5ML

COSENTYX SOLUTION FOR INJECTION IN PREFILLED SENSOREADY PEN 150MG/ML

COSENTYX SOLUTION FOR INJECTION IN PRE-FILLED UNOREADY PEN 300MG/2ML

Active Ingredient

Secukinumab

Product Registrant

Novartis (Singapore) Pte Ltd.

Date of Approval

06/09/2023

Indications:

Cosentyx is indicated for the treatment of moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic therapy (See clinical trials section).

Product Name

BRUKINSA CAPSULE 80 MG

Active Ingredient

Zanubrutinib

Product Registrant

BEIGENE SINGAPORE PTE LTD

Date of Approval

08/09/2023

Indications:

BRUKINSA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [see Clinical Studies (14.4)].

Product Name

STAMICIS KIT FOR RADIOPHARMACEUTICAL PREPARATION 1MG

Active Ingredient

Tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate

Product Registrant

QT INSTRUMENTS (S) PTE LTD

Date of Approval

15/09/2023

Indications:

· Assessment of global ventricular function. First-pass technique for determination of ejection fraction and/or ECG-triggered, gated SPECT for evaluation of left ventricular ejection fraction, volumes and regional wall motion.

· Localisation of hyperfunctioning parathyroid tissue in patients with recurrent or persistent disease in both primary and secondary hyperparathyroidism, and in patients with primary hyperparathyroidism scheduled to undergo initial surgery of the parathyroid glands.

Product Name

TUKYSA FILM-COATED TABLETS 50 MG AND 150 MG

Active Ingredient

Tucatinib

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

18/09/2023

Indications:

TUKYSA is indicated in combination with trastuzumab for the treatment of patients with RAS wild-type, HER2- positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

Product Name

ENHERTU POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL

Active Ingredient

Trastuzumab deruztecan

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

20/09/2023

Indications:

ENHERTU is indicated for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy.

Product Name

OZEMPIC 1MG/DOSE SOLUTION FOR INJECTION IN PREFILLED PEN 1.34MG/ML

OZEMPIC 0.25MG, 0.5MG/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MG/ML

Active Ingredient

Semaglutide

Product Registrant

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Date of Approval

22/09/2023

Indications:

To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease (see Pharmacodynamic Properties).

Product Name

IMBRUVICA FILM-COATED TABLETS 140MG, 280MG AND 420MG

Active Ingredient

Ibrutinib

Product Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Date of Approval

27/09/2023

Indications:

Chronic lymphocytic leukemia / Small lymphocytic lymphoma (CLL/SLL)

IMBRUVICA® as a single agent, or in combination with rituximab or obinutuzumab or venetoclax, is indicated for the treatment of adult patients with previously untreated CLL/SLL.

Product Name

REVOLADE TABLET 25MG AND 50MG

Active Ingredient

Eltrombopag olamine

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

28/09/2023

Indications:

Revolade is indicated for immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Revolade is indicated for immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis in paediatric patients aged 6 years and above who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).