New drug approvals - October 2024

Active Ingredient (Strength)

Abiraterone acetate(500mg),Niraparib tosylate monohydrate eqv niraparib(50mg),
Abiraterone acetate(500mg),Niraparib tosylate monohydrate eqv niraparib(100mg)

Application type

NDA-2: New combination

Product Registrant

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Date of Approval

14/10/2024

Registration No.

SIN17109P,
SIN17110P

Indications:
AKEEGA®, the combination of niraparib and abiraterone acetate with prednisone or prednisolone, is indicated as treatment for adults with metastatic castration-resistant prostate cancer (mCRPC) and BReast CAncer (BRCA) gene mutations (germline and/or somatic), in whom chemotherapy is not clinically indicated.

Active Ingredient (Strength)

Vutrisiran (as vutrisiran sodium)(25mg)

Application type

NDA-1: New chemical entity

Product Registrant

NYPRAX PHARMA PTE. LTD.

Date of Approval

25/10/2024

Registration No.

SIN17124P

Indications:
Amvuttra is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy.

Active Ingredient (Strength)

BILASTINE(20.00 mg)

Application type

NDA-2: New forensic classification

Product Registrant

A. MENARINI SINGAPORE PTE. LTD.

Date of Approval

02/10/2024

Registration No.

SIN17104P

Indications:
Bilaxten contains the active substance bilastine which is an antihistamine. Bilaxten is used to relieve the symptoms of hayfever (sneezing, itchy, runny, blocked-up nose and red and watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (hives or urticaria).

Active Ingredient (Strength)

Epcoritamab(4.0mg/0.8mL),
Epcoritamab(48mg/0.8mL),
Epcoritamab(4.0mg/0.8mL),
Epcoritamab(48mg/0.8mL)

Application type

NDA-1 and NDA-2: New biological entity

Product Registrant

ABBVIE PTE. LTD.

Date of Approval

02/10/2024

Registration No.

SIN17105P,
SIN17106P,
SIN17105P,
SIN17106P

Indications:
EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Active Ingredient (Strength)

Fruquintinib(5mg),
Fruquintinib(1mg)

Application type

NDA-1 and NDA-3: New chemical entity

Product Registrant

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Date of Approval

17/10/2024

Registration No.

SIN17113P,
SIN17114P

Indications:
Fruquintinib is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC)who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-basedchemotherapy, an anti-VEGF agent, and, if RAS wild-type, an anti-EGFR agent.
 
*Evaluated via Access and Project Orbis

Active Ingredient (Strength)

Adalimumab(20 mg/0.4 mL)

Application type

NDA-2: New presentation

Product Registrant

SANDOZ SINGAPORE PTE. LTD.

Date of Approval

17/10/2024

Registration No.

SIN17117P

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.
Pediatric Ulcerative Colitis
Hyrimoz is indicated for inducing and maintaining clinical remission in pediatric patients 5 years of age or older with moderately to severely active ulcerative colitis 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.

Active Ingredient (Strength)

Andusomeran(0.05mg/0.5ml),
Andusomeran(0.05mg / 0.5ml)

Application type

NDA-2: New presentation

Product Registrant

MODERNA BIOTECH SINGAPORE PTE. LTD.

Date of Approval

30/10/2024

Registration No.

SIN17128P,
SIN17129P

Indications:
Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID-19 disease caused by SARS- CoV-2 in individuals 12 years of age and older (see sections 4.2 and 5.2

Active Ingredient (Strength)

Asfotase alfa(100mg/mL),
Asfotase alfa(40mg/mL)

Application type

NDA-1: New biological entity

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

29/10/2024

Registration No.

SIN17126P,
SIN17127P

Indications:
STRENSIQ is indicated for long-term enzyme replacement therapy in patients with pediatric-onsethypophosphatasia (HPP).

Active Ingredient (Strength)

Capivasertib(200mg),
Capivasertib(160mg)

Application type

NDA-1 and NDA-3: New chemical entity

Product Registrant

ASTRAZENECA SINGAPORE PTE LTD

Date of Approval

14/10/2024

Registration No.

SIN17111P,
SIN17112P

Indications:
TRUQAP is indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alteration following recurrence or progression on or after an endocrine-based regimen.

Evaluated as part of Project Orbis