New drug approvals - July 2021

Product Name

HYRIMOZ SOLUTION FOR INJECTION IN PRE-FILLED PEN 40MG/0.8ML

Active Ingredient

Adalimumab

Application type

NDA-2: New dosage form

Product Registrant

NOVARTIS (SINGAPORE) PTE LTD

Date of Approval

08/07/2021

Registration No.

SIN16273P

Indications:

ADULTS

Rheumatoid Arthritis

Hyrimoz is indicated for reducing signs and symptoms and inhibiting the progression of structural damage and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs. Hyrimoz can be used alone or in combination with methotrexate or other DMARDs.

Hyrimoz, in combination with MTX, can also be used in the treatment of patients with recently diagnosed moderate to severely active rheumatoid arthritis who have not received methotrexate.

Psoriatic Arthritis

Hyrimoz is indicated for reducing signs and symptoms of active arthritis in adult patients with moderate to severe psoriatic arthritis when the response to previous DMARD therapy has been inadequate. Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.

Hyrimoz can be used alone or in combination with DMARDs.

Ankylosing Spondylitis

Hyrimoz is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis who have had an inadequate response to conventional therapy.

Crohn’s Disease

Hyrimoz is indicated for the treatment of moderate to severe active Crohn’s disease in adults to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients who have had an inadequate response to conventional therapies, or who have lost response to or are intolerant of infliximab. For induction treatment, Hyrimoz should be given in combination with corticosteroids. Hyrimoz can be given as monotherapy in case of intolerance to corticosteroids or when continued treatment with corticosteroids is inadequate.

Ulcerative Colitis

Hyrimoz is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Plaque Psoriasis

Hyrimoz is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy and when other systemic therapies are medically less appropriate.

Hidradenitis Suppurativa

Hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.

Uveitis

Hyrimoz is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.

PEDIATRICS

Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis

Hyrimoz in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA), in patients 2 years of age and older, who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDS). Hyrimoz can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see Clinical Efficacy and Safety). Adalimumab has not been studied in patients aged less than 2 years.

Enthesitis-Related Arthritis

Hyrimoz is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.

Pediatric Crohn's Disease

Hyrimoz is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients, 6 years of age and older, with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.

Pediatric Plaque Psoriasis

Hyrimoz is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.

Adolescent Hidradenitis Suppurativa

Hyrimoz is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic hidradenitis suppurativa (HS) therapy.

Pediatric Uveitis

Hyrimoz is indicated for the treatment of chronic non-infectious anterior uveitis in pediatric patients 2 years of age and older who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.

Product Name

TECHNESCAN PYP, KIT FOR RADIOPHARMACEUTICAL PREPARATION, 20MG/VIAL

Active Ingredient

Sodium pyrophosphate decahydrate

Application type

NDA-1: New chemical entity

Product Registrant

LICENCE HOLDER IN CAPS

Date of Approval

09/07/2021

Registration No.

SIN16274P

Indications:

This medicinal product is for diagnostic use only.

1. In-vivo or in-vivo/in-vitro red blood cell labelling for blood pool scintigraphy.

   Major indications are:

   - angiocardioscintigraphy for:

   * evaluation of ventricular ejection fraction

   * evaluation of global and regional cardiac wall motion

   * myocardial phase imaging

   - organ perfusion and vascular abnormalities imaging

   - diagnosis and localization of occult gastro-intestinal bleeding

2. Determination of blood volume

3. Spleen scintigraphy

Product Name

KOSELUGO HARD CAPSULES 10MG/ 25MG

Active Ingredient

Selumetinib

Application type

NDA-1/ 3

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

09/07/2021

Registration No.

SIN16275P, SIN16276P

Indications:

KOSELUGO is indicated for the treatment of paediatric patients aged 3 years and above with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

*Evaluated as part of Project Orbis

Product Name

PERTAGEN SUSPENSION FOR INJECTION

Active Ingredient

Filamentous Haemagglutinin, Recombinant Pertussis Toxin

Application type

NDA-2

Product Registrant

NOVEM HEALTHCARE PTE LTD

Date of Approval

23/07/2021

Registration No.

SIN16283P

Indications:

Pertagen®is indicated for active booster immunization against pertussis in individuals from the age of 11 years onwards.Pertagen®may be considered as an alternative to combined tetanus, diphtheria and acellular pertussis vaccines in persons having received multiple and frequent tetanus and diphtheria vaccine doses including persons with known hypersensitivity to tetanus (Arthus-type hypersensitivity reaction) or diphtheria vaccines.

Product Name

ZIRABEV SOLUTION FOR INJECTION 100 mg/4 mL,

ZIRABEV SOLUTION FOR INJECTION 400 mg/16 mL

Active Ingredient

Bevacizumab (PF-06439535)

Application type

NDA-2/3

Product Registrant

PFIZER PRIVATE LIMITED

Date of Approval

26/07/2021

Registration No.

SIN16286P, SIN16287P

Indications:

Metastatic Carcinoma of the Colon or Rectum (mCRC)

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

Metastatic Breast Cancer (mBC)

ZIRABEV, in combination with paclitaxel, is indicated for the treatment of patients who have not received chemotherapy for metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

ZIRABEV, 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 ZIRABEV in combination with capecitabine.

The effectiveness of bevacizumab in metastatic breast cancer 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 bevacizumab in breast cancer.

Non-Small Cell Lung Cancer (NSCLC)

ZIRABEV, 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.

ZIRABEV, 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.

Malignant Glioma (WHO Grade IV) - Glioblastoma

ZIRABEV, as a single agent, is indicated for the treatment of patients with glioblastoma after relapse or disease progression following prior therapy.

The effectiveness of bevacizumab in glioblastoma is based on an improvement in objective response rate. There are no data demonstrating an improvement in disease-related symptoms or increased survival with bevacizumab.

Advanced and/or Metastatic Renal Cell Cancer (mRCC)

ZIRABEV, 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

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

ZIRABEV, 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 vascular endothelial growth factor (VEGF)-targeted angiogenesis inhibitors.

ZIRABEV, 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

ZIRABEV, 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

ACCOFIL SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED SYRINGE 48 MU/0.5ML AND 30 MU/0.5ML

Active Ingredient

Filgrastim

Application type

NDA-2/3

Product Registrant

ACCORD HEALTHCARE PRIVATE LIMITED

Date of Approval

08/07/2021

Registration No.

SIN16267P and SIN16268P

Indications:

Established cytotoxic chemotherapy

Accofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia and its clinical sequelae in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.

Peripheral blood progenitor cell mobilisation (PBPC)

Accofil is indicated for the mobilisation of autologous peripheral blood progenitor cells (PBPC) alone, or following myelosuppressive chemotherapy and the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic PBPC).

Severe chronic neutropenia (SCN)

Long-term administration of Neupogen is indicated in patients, children or adults, with severe congenital, cyclic or idiopathic neutropenia with an Absolute Neutrophil Count (ANC) ≤ 0.5 x 109/l, and a history of severe or recurrent infections, to increase neutrophil counts and to reduce the incidence and duration of infection-related events.

HIV infection

Accofil is indicated for the treatment of persistent neutropenia (ANC ≤ 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.