New drug indication approval - May 2023

Product Name

REXULTI FILM COATED TABLETS 0.25MG, 0.5MG, 1MG, 2MG, 3MG, 4MG

Active Ingredient

Brexpiprazole

Product Registrant

LUNDBECK SINGAPORE PTE LTD

Date of Approval

02/05/2023

Indications:

Treatment of schizophrenia (see section 5.1) in adults and pediatric patients aged 13 years and older.

Product Name

RINVOQ EXTENDED-RELEASE TABLET 15MG, 30MG, 45MG

Active Ingredient

Upadacitinib Hemihydrate eqv Upadacitinib

Product Registrant

ABBVIE PTE. LTD.

Date of Approval

11/05/2023

Indications:

RINVOQ is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI), who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs).

RINVOQ is indicated for the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.

Product Name

KEYTRUDA SOLUTION FOR INFUSION 25 MG/ML

Active Ingredient

Pembrolizumab

Product Registrant

MSD PHARMA (SINGAPORE) PTE. LTD.

Date of Approval

17/05/2023

Indications:

Melanoma

KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC or III melanoma who have undergone complete resection.

*Evaluated as part of Project Orbis

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with an anti-angiogenic tyrosine kinase inhibitor (TKI).

Renal Cell Carcinoma

KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of patients with advanced RCC.

Endometrial Carcinoma

KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Product Name

FORXIGA TABLET 5MG, 10MG

Active Ingredient

Dapagliflozin propanediol

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

26/05/2023

Indications:

FORXIGA is indicated in adults with heart failure (NYHA class II-IV) to reduce the risk of cardiovascular death and hospitalization for heart failure (see section 5.1).