New drug approvals - Nov 2020

Product Name

MAYZENT FILM-COATED TABLETS 0.25MG AND 2MG

Active Ingredient

Siponimod

Application type

NDA-1: New chemical entity

Product Registrant

Novartis (Singapore) Pte Ltd

Date of Approval

16 Nov 2020

Registration No.

SIN16039P, SIN16040P

Indications:

Mayzent is indicated for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity (see section 5.1).

Product Name

FASENRA SOLUTION FOR INJECTION 30MG/ML (AUTOINJECTOR PEN)

Active Ingredient

Benralizumab

Application type

NDA-2: New dosage form

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

18/11/2020

Registration No.

SIN16043P

Indications:

FASENRA is indicated as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting β-agonists.

Product Name

ADYNOVATE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 250IU/ 500IU/ 1000IU/ 1500IU/ 2000IU/ 3000IU

Active Ingredient

Rurioctocog alfa pegol [Antihemophilic Factor (Recombinant), PEGylated]

Application type

NDA-1 and NDA-3: New biological entity and new strength

Product Registrant

Takeda Pharmaceuticals (Asia Pacific) Pte. Ltd.

Date of Approval

24 Nov 2020

Registration No.

SIN16048P, SIN16049P, SIN16050P, SIN16051P, SIN16052P, SIN16053P

Indications:

ADYNOVATE, Rurioctocog alfa pegol [Antihaemophilic Factor (Recombinant), PEGylated], is a human antihaemophilic factor indicated in children and adults with haemophilia A (congenital factor VIII deficiency) for:

• On-demand treatment and control of bleeding episodes

• Perioperative management

• Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use

ADYNOVATE is not indicated for the treatment of von Willebrand disease.

Product Name

TRAZIMERA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 440MG

Active Ingredient

Trastuzumab

Application type

NDA-2

Product Registrant

Pfizer Private Limited

Date of Approval

11 Nov 2020

Registration No.

SIN16038P

Indications:

Metastatic breast cancer (MBC)

TRAZIMERA is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress human epidermal growth factor receptor 2 (HER2):

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

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

- in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive metastatic breast cancer, not previously treated with trastuzumab. This indication is based on data from one Phase III trial which studied the use of trastuzumab in combination with anastrozole (see section 5.1). Experience with other aromatase inhibitors is limited.

Early breast cancer (EBC)

TRAZIMERA 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 5.1).

- 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 TRAZIMERA therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter (see sections 4.4 and 5.1).

TRAZIMERA should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1).

Metastatic gastric cancer (MGC)

TRAZIMERA 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.

TRAZIMERA 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 (see sections 4.4 and 5.1).