New drug approvals - June 2021

Product Name

VYZULTA (LATANOPROSTENE BUNOD) OPHTHALMIC SOLUTION 0.024%

Active Ingredient

Latanoprostene Bunod

Application type

NDA-1: New chemical entity

Product Registrant

Bausch & Lomb (Singapore) Private Limited

Date of Approval

01/06/2021

Registration No.

SIN16214P

Indications:

VYZULTA™ (latanoprostene bunod ophthalmic solution, 0.024%) is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Pediatrics (≤ 18 years of age): No data are available in patients below 18 years old; therefore, VYZULTA is not indicated for use in pediatrics.

Geriatrics (≥ 65 years of age):Evidence from clinical studies and experience suggests that safety and effectiveness is comparable between elderly and other adult patients.

Product Name

RYBELSUS TABLET 3MG, 7MG AND 14MG

Active Ingredient

Semaglutide

Application type

NDA-1: New chemical entity

NDA-3: New strength

Product Registrant

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

Date of Approval

01/06/2021

Registration No.

SIN16251P, SIN16216P, SIN16217P

Indications:

Rybelsus® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise

• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications

• in combination with other medicinal products for the treatment of diabetes.

Product Name

IMBRUVICA FILM-COATED TABLETS 140MG, 280MG, 420MG, 560MG

Active Ingredient

Ibrutinib

Application type

NDA-2: New dosage form

NDA-3: New strength

Product Registrant

JOHNSON & JOHNSON PTE. LTD.

Date of Approval

03/06/2021

Registration No.

SIN16218P, SIN16219P, SIN16220P, SIN16221P

Indications:

Mantle Cell Lymphoma (MCL)

IMBRUVICA^®is indicated for the treatment of adult patients with MCL who have received at least one prior therapy. In the clinical study, efficacy was demonstrated based on overall response rate. Improvements in survival or disease-related symptoms have not been established.

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

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

IMBRUVICA^®as a single agent, or in combination with bendamustine and rituximab, is indicated for the treatment of patients with CLL/SLL who have received at least one prior therapy.

Chronic lymphocytic leukemia / Small lymphocytic lymphoma (CLL/SLL) with 17p deletion

IMBRUVICA^®is indicated for the treatment of patients with CLL/SLL with 17p deletion.

Waldenström’s macroglobulinemia (WM)

IMBRUVICA^®as a single agent, or in combination with rituximab, is indicated for the treatment of patients with WM.

Product Name

MYLOTARG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 5MG/ VIAL

Active Ingredient

Gemtuzumab ozogamicin

Application type

NDA-1: New biological entity

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

21/06/2021

Registration No.

SIN16243P

Indications:

MYLOTARG is indicated for:

o Newly-diagnosed acute myeloid leukemia (AML) (combination therapy)

 Combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive AML, except acute promyelocytic leukemia (APL) (see Sections 4.4 and 5.1).

Product Name

PELGRAZ SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE 6MG/0.6ML

Active Ingredient

Pegfilgrastim

Application type

NDA-2: Biosimilar

Product Registrant

ACCORD HEALTHCARE PRIVATE LIMITED

Date of Approval

24/06/2021

Registration No.

SIN16249P

Indications:

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Product Name

PHESGO SOLUTION FOR INJECTION 1200 MG/600 MG/15 ML, 600 MG/600 MG/10 ML

Active Ingredient

Pertuzumab, Trastuzumab

Application type

NDA-2: New combination/dosing regimen

NDA-3: New strength

Product Registrant

ROCHE SINGAPORE PTE. LTD.

Date of Approval

22/06/2021

Registration No.

SIN16247P, SIN16248P

Indications:

Early Breast Cancer (EBC)

Phesgo is indicated for use in combination with chemotherapy for the:

•neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or earlystage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer (see 3.1.2 Clinical studies). This indication is based on demonstration of an improvement in pathological complete response rate. No data are available demonstrating improvement in event-free survival or overall survival.

•adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence(see 3.1.2 Clinical Studies)

Metastatic Breast Cancer (MBC)

Phesgo is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.