New drug indication approval - March 2023

Product Name

LYNPARZA FILM-COATED TABLET 100MG

LYNPARZA FILM-COATED TABLET 150MG

Active Ingredient

Olaparib

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

16/03/2023

Indications:

Lynparza in combination with abiraterone and prednisone or prednisolone is indicated for the:

• treatment of adult patients with metastatic castration-resistant prostate cancer in whom chemotherapy is not clinically indicated (see Section 5.1).

Product Name

COSENTYX SOLUTION FOR INJECTION IN PREFILLED

SENSOREADY PEN 150MG/ML

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

SYRINGE 300MG/2ML

COSENTYX SOLUTION FOR INJECTION IN PREFILLED

UNOREADY PEN 300MG/2ML

Active Ingredient

Secukinumab

Product Registrant

Novartis (Singapore) Pte. Ltd

Date of Approval

17/03/2023

Indications:

Enthesitis-Related Arthritis (ERA)

Cosentyx is indicated for the treatment of active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Juvenile Psoriatic Arthritis (JPsA)

Cosentyx is indicated for the treatment of active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

Product Name

VALDOXAN TABLET 25 MG

Active Ingredient

Agomelatine

Product Registrant

SERVIER (S) PTE LTD

Date of Approval

27/03/2023

Indications:

Valdoxan is indicated for the treatment of generalised anxiety disorder (GAD).

Product Name

VEKLURY LYOPHILIZED POWDER FOR IV INFUSION 100MG/VIAL

Active Ingredient

Remdesivir

Product Registrant

GILEAD SCIENCES SINGAPORE PTE LTD

Date of Approval

30/03/2023

Indications:

VEKLURY is indicated for the treatment of coronavirus disease 2019 (COVID-19) in:

• adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with pneumonia requiring supplemental oxygen. In clinical studies, there were no survival and recovery benefit with VEKLURY in patients under invasive mechanical ventilation (IMV), or under extracorporeal membrane oxygenation (ECMO).

• adults and adolescent patients (aged 12 years and above and weighing at least 40 kg) who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.

[see Clinical Studies (13)]