New drug approvals - June 2023

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Product Name

SONDELBAY INJECTION 20 MCG/80 MCL

Active Ingredient

Teriparatide

Application type

NDA-2: Biosimilar

Product Registrant

ACCORD HEALTHCARE PRIVATE LIMITED

Date of Approval

01/06/2023

Registration No.

SIN16802P

Indications:

Sondelbay is indicated:

· For the treatment of postmenopausal women with osteoporosis who are at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant of previous osteoporosis therapy, based upon physician assessment. In postmenopausal women with osteoporosis, teriparatide increases BMD and reduces the risk of vertebral and nonvertebral fractures.

· To increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. These include men with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment. In men with primary or hypogonadal osteoporosis, teriparatide increases BMD. The effects of teriparatide on risk for fracture in men have not been studied.

· For the treatment of men and women with glucocorticoid-induced osteoporosis at high risk for fracture. See CLINICAL STUDIES (12.3).

 

Product Name

CAMZYOS CAPSULES 2.5MG

CAMZYOS CAPSULES 5MG

CAMZYOS CAPSULES 10MG

CAMZYOS CAPSULES 15MG

Active Ingredient

Mavacamten

Application type

NDA-1: New chemical

NDA-3: New strength

Product Registrant

LIANBIO DEVELOPMENT (SG) PTE. LTD.

Date of Approval

14/06/2023

Registration No.

SIN16804P, SIN16805P, SIN16806P, SIN16807P

Indications:

CAMZYOS is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.

 

Product Name

VEGZELMA CONCENTRATE FOR SOLUTION FOR INFUSION 25 MG/ML

Active Ingredient

Bevacizumab

Application type

NDA-2: Biosimilar

Product Registrant

CELLTRION HEALTHCARE SINGAPORE PRIVATE LIMITED

Date of Approval

16/06/2023

Registration No.

SIN16810P

Indications:

Metastatic carcinoma of the colon or rectum(mCRC)

Vegzelma in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of patients with metastatic carcinoma of the colon or rectum.

Metastatic Breast Cancer (mBC)

Vegzelma in combination with paclitaxel is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer.

Vegzelma in combination with capecitabine is indicated for first-line treatment of patients with HER2-negative metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Vegzelma in combination with capecitabine.

The effectiveness of Vegzelma in metastatic breast cancer (mBC) is based on an improvement in progression-free survival. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vegzelma in breast cancer.

Non-Small Cell Lung Cancer (NSCLC)

Vegzelma, in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.

Vegzelma, in combination with erlotinib, is indicated for first-line treatment of patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations.

Advanced and/or metastatic Renal Cell Cancer (mRCC)

Vegzelma in combination with interferon alfa-2a is indicated for first-line treatment of patients with advance and/or metastatic renal cell cancer.

Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Vegzelma, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of advanced (FIGO stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Vegzelma, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel is indicated for the treatment of patients with recurrent, platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors.

Vegzelma in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.

Cervical Cancer

Vegzelma in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent, or metastatic carcinoma of the cervix.

 

Product Name

NUCALA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 40MG/0.4ML

Active Ingredient

Mepolizumab

Application type

NDA-2: New strength / indication / dosing regimen

Product Registrant

GLAXOSMITHKLINE PTE LTD

Date of Approval

19/06/2023

Registration No.

SIN16811P

Indications:

Severe Eosinophilic Asthma

NUCALA is indicated as add-on maintenance treatment of severe eosinophilic asthma in patients 6 to 11 years old (see Clinical Studies).


Healthcare professional, Industry member, Therapeutic Products
Published:

New Drug Approvals