New drug approvals - May 2021

  • Please click here for a list of summary reports of benefit-risk assessments. 

 

Product Name

REPLAGAL CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML

Active Ingredient

Agalsidase alfa

Application type

NDA-1: New biological entity

Product Registrant

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Date of Approval

17/05/2021

Registration No.

SIN16197P

Indications:

Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency).

 

Product Name

APROVASC FILM COATED TABLET 150MG/5MG, 300MG/5MG, 300MG/10MG

Active Ingredient

Irbesartan, amlodipine besilate

Application type

NDA-2: New combination

Product Registrant

SANOFI-AVENTIS SINGAPORE PTE. LTD.

Date of Approval

14/05/2021

Registration No.s

SIN16194P, SIN16195P, SIN16196P

Indications:

Treatment of essential hypertension.

Aprovasc® is indicated in the treatment of hypertension in adult patients in whom blood pressure is not adequately controlled on irbesartan or amlodipine monotherapy.

 

Product Name

REMLEAS HARD CAPSULES 40MG

Active Ingredient

Valbenazine ditosylate 73mg eqv valbenazine 40mg

Application type

NDA-1: New chemical entity

Product Registrant

MITSUBISHI TANABE PHARMA SINGAPORE PTE LTD

Date of Approval

19/5/2021

Registration No.

SIN16198P

Indications:

REMLEAS is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.

 

Product Name

KANJINTI POWDER FOR INJECTION 150MG/VIAL AND 440MG/VIAL

Active Ingredient

Trastuzumab

Application type

NDA-2: Biosimilar

NDA-3: New strength

Product Registrant

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Date of Approval

25/5/2021

Registration No.

SIN16206P, SIN16207P

Indications:

Metastatic Breast Cancer (MBC)

KANJINTI is indicated for the treatment of patients with metastatic breast cancer who have tumors that overexpress HER2:

a) as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease

b) in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease

c) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with KANJINTI. This indication is based on data from one Phase III trial which studied the use of KANJINTI in combination with anastrozole (see 3.1.2 Clinical / Efficacy Studies).

Experience with other aromatase inhibitors is limited.

Early Breast Cancer (EBC)

KANJINTI is indicated for the treatment of patients with HER2 positive early breast cancer.

- following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 3.1).

- following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.

- in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.

- in combination with neoadjuvant chemotherapy followed by adjuvant KANJINTI therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 2.4 and 3.1).

KANJINTI should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

Metastatic Gastric Cancer (MGC)

KANJINTI in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

KANJINTI should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.

 

Product Name

EVENITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 105 MG/1.17 ML

Active Ingredient

Romosozumab

Application type

NDA-1: New chemical entity

Product Registrant

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Date of Approval

27/5/2021

Registration No.

SIN16208P

Indications:

EVENITY is indicated for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.

 

Product Name

CRYSVITA® SOLUTION FOR INJECTION 10MG/ML, 20MG/ML, 30MG/ML

Active Ingredient

Burosumab

Application type

NDA-1: New chemical entity, NDA-3: New strengths

Product Registrant

Kyowa Kirin Asia Pacific Pte Ltd

Date of Approval

3/5/2021

Registration No.

SIN16176P, SIN16177P, SIN16178P

Indications:

CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older.


Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals