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Prescription medicines: registration of new chemical entities in Australia

24 May 2022

Each year, TGA registers approximately 40 new prescription medicines containing new active substances. We refer to these as New Chemical Entities (NCEs) or New Biological Entities (NBEs).

Some of these NCEs/NBEs are innovative or 'first-in-class', and have been made available to the public for the first time outside the controlled environment of a clinical trial.

This decision by TGA to register a NCE/NBE often comes after years of research and development and following a comprehensive review by TGA scientists and clinicians of the medicine's quality, safety and efficacy.

Throughout the year, we will be publishing information on the new prescription medicines as they are approved. However, it may still be some time before the sponsor (pharmaceutical company) decides to supply the product in Australia.

The trade name, active ingredient, and sponsor for each new prescription medicine reflects the information initially entered in the Australian Register of Therapeutic Goods (ARTG).

Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.

Approval times are reported in the number of TGA working days for each new registration, along with the legislated timeframe (unless otherwise indicated) for that category of application in brackets.


symbol denoting an orphan drug

Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market

symbol denoting a priority determination

Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available

symbol denoting a provisional registration

Provisional registration: involves early access to vital and life-saving medicines through time-limited registration


Registration of NCEs, 2022

Previous years

2021 2020 2019 2018 2017 2016 2015 2014

March 2022

LUMAKRAS orphan drug

Evaluation commenced: 1 Mar 2021

Registration decision: 28 Mar 2022

Date registered: 30 Mar 2022

Approval time: 244 (255 working days)

sotorasib

Amgen Australia Pty Ltd

LUMAKRAS (film-coated tablet) has provisional approval in Australia for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy for advanced disease.

The decision to approve this indication has been made on the basis of the objective response rate (ORR) and the duration of response (DOR). Continued approval of this indication depends on the verification and description of benefit in confirmatory trials.

SAPHNELO

Evaluation commenced: 1 Feb 2021

Registration decision: 24 Mar 2022

Date registered: 29 Mar 2022

Approval time: 235 (255 working days)

anifrolumab

AstraZeneca Pty Ltd

SAPHNELO (anifrolumab) (concentrated injection) is indicated as add on treatment of adult patients with moderate to severe, active systemic lupus erythematosus (SLE), despite standard therapy.

The safety and efficacy of SAPHNELO have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.

YONSA MPRED

Evaluation commenced: 2 Nov 2020

Registration decision: 24 Mar 2022

Date registered: 29 Mar 2022

Approval time: 206 (255 working days)

abiraterone acetate; methylprednisolone

Sun Pharma ANZ Pty Ltd

New Combination

YONSA MPRED (tablet) is indicated for the treatment of patients with:

  • newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT), or
  • patients with metastatic advanced prostate cancer (castration resistant prostate cancer, mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) or
  • patients with mCRPC who have received prior chemotherapy containing a taxane.

BIMZELX

Evaluation commenced: 1 Mar 2021

Registration decision: 17 Mar 2022

Date registered: 24 Mar 2022

Approval time: 216 (255 working days)

bimekizumab

UCB Pharma (division of UCB Australia Pty Ltd)

BIMZELX (solution for injection) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

VAXELIS

Evaluation commenced: 1 Jun 2021

Registration decision: 22 Mar 2022

Date registered: 23 Mar 2022

Approval time: 158 (255 working days)

DTPa5-HB-IPV-Hib

Maxx Pharma Pty Ltd

VAXELIS (DTPa5-HB-IPV-Hib) (suspension for injection) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).

The use of VAXELIS should be in accordance with official recommendations.

VUMERITY

Evaluation commenced: 31 Mar 2021

Registration decision: 18 Mar 2022

Date registered: 21 Mar 2022

Approval time: 197 (255 working days)

diroximel fumarate

Biogen Australia Pty Ltd

VUMERITY (enteric capsule) is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

PONVORY

Evaluation commenced: 26 Jul 2021

Registration decision: 7 Mar 2022

Date registered: 11 Mar 2022

Approval time: 112 (255 working days)

ponesimod

Janssen-Cilag Pty Ltd

PONVORY (film-coated tablet) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

XPOVIO

Evaluation commenced: 2 Dec 2020

Registration decision: 3 Mar 2022

Date registered: 8 Mar 2022

Approval time: 242 (255 working days)

selinexor

Antengene (Aus) Pty Ltd

Xpovio (film-coated tablet) is indicated:

  • In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
  • In combination with dexamethasone for the treatment of adult patients with relapsed orrefractory multiple myeloma (RRMM) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory medicinal product (IMiD), and an anti-CD38 monoclonal antibody (mAb).

February 2022

EVUSHELD provisional registration

Evaluation commenced: 2 Dec 2021

Registration decision: 24 Feb 2022

Date registered: 26 Feb 2022

Approval time: 54 (255 working days)

cilgavimab; tixagevimab

AstraZeneca Pty Ltd

EVUSHELD (solution for injection) has provisional approval for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg,

  • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination or
  • For whom vaccination with any approved COVID-19 vaccine is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID?19 vaccine component(s).

See Section 4.2 Dose and method of administration and Section 5.2 Pharmacokinetic properties.

EVUSHELD is not recommended as a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

This decision has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety data from ongoing clinical trials.

EVUSHELD

Evaluation commenced: 2 Dec 2021

Registration decision: 24 Feb 2022

Date registered: 26 Feb 2022

Approval time: 54 (255 working days)

cilgavimab; tixagevimab

AstraZeneca Pty Ltd

EVUSHELD (solution for injection) has provisional approval for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg,

  • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments that make it likely that they will not mount an adequate immune response to COVID-19 vaccination or
  • For whom vaccination with any approved COVID-19 vaccine is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID?19 vaccine component(s).

See Section 4.2 Dose and method of administration and Section 5.2 Pharmacokinetic properties.

EVUSHELD is not recommended as a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

This decision has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety data from ongoing clinical trials.

SOGROYA

Evaluation commenced: 1 Jun 2021

Registration decision: 14 Feb 2022

Date registered: 21 Feb 2022

Approval time: 133 (255 working days)

somapacitan

Novo Nordisk Pharmaceuticals Pty Ltd

SOGROYA (solution for injection) is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).

SOGROYA

Evaluation commenced: 1 Jun 2021

Registration decision: 14 Feb 2022

Date registered: 21 Feb 2022

Approval time: 133 (255 working days)

somapacitan

Novo Nordisk Pharmaceuticals Pty Ltd

SOGROYA (solution for injection) is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).

JEMPERLI

Evaluation commenced: 1 Feb 2021

Registration decision: 15 Feb 2022

Date registered: 17 Feb 2022

Approval time: 208 (255 working days)

dostarlimab

GlaxoSmithKline Australia Pty Ltd

JEMPERLI (solution for infusion) is indicated as monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.

This medicine and indication have provisional approval, based on objective response rate and duration of response in a single-arm trial. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.

JEMPERLI provisional registration

Evaluation commenced: 1 Feb 2021

Registration decision: 15 Feb 2022

Date registered: 17 Feb 2022

Approval time: 208 (255 working days)

dostarlimab

GlaxoSmithKline Australia Pty Ltd

JEMPERLI (solution for infusion) is indicated as monotherapy for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.

This medicine and indication have provisional approval, based on objective response rate and duration of response in a single-arm trial. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.

RYBELSUS

Evaluation commenced: 2 Nov 2020

Registration decision: 4 Feb 2022

Date registered: 7 Feb 2022

Approval time: 203 (255 working days)

semaglutide

Novo Nordisk Pharmaceuticals Pty Ltd

RYBELSUS (tablet) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

  • as monotherapy if metformin is considered inappropriate due to intolerance or contraindications; or
  • in combination with other medicinal products for the treatment of type 2 diabetes mellitus.

RYBELSUS

Evaluation commenced: 2 Nov 2020

Registration decision: 4 Feb 2022

Date registered: 7 Feb 2022

Approval time: 203 (255 working days)

semaglutide

Novo Nordisk Pharmaceuticals Pty Ltd

RYBELSUS (tablet) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

  • as monotherapy if metformin is considered inappropriate due to intolerance or contraindications; or
  • in combination with other medicinal products for the treatment of type 2 diabetes mellitus.

EMPAVELI orphan drug

Evaluation commenced: 30 Nov 2020

Registration decision: 28 Jan 2022

Date registered: 3 Feb 2022

Approval time: 243 (255 working days)

pegcetacoplan

Apellis Australia Pty Ltd

EMPAVELI (solution for injection) is indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have an inadequate response to, or are intolerant of, a C5 inhibitor.

EMPAVELI orphan drug

Evaluation commenced: 30 Nov 2020

Registration decision: 28 Jan 2022

Date registered: 3 Feb 2022

Approval time: 243 (255 working days)

pegcetacoplan

Apellis Australia Pty Ltd

EMPAVELI (solution for injection) is indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have an inadequate response to, or are intolerant of, a C5 inhibitor.

January 2022

LAGEVRIO

Evaluation commenced: 17 Aug 2021

Registration decision: 18 Jan 2022

Date registered: 20 Jan 2022

Approval time: 104 (255 working days)

molnupiravir

Merck Sharp & Dohme (Australia) Pty Ltd

LAGEVRIO (capsule) has provisional approval for the treatment of adults with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death (see section 5.1 Pharmacodynamic properties - clinical trials).

The decision to approve this indication has been made on the basis of the analysis of efficacy and safety data from a Phase 3 trial. Continued approval of this indication depends on additional data.

NUVAXOVID

Evaluation commenced: 26 Feb 2021

Registration decision: 19 Jan 2022

Date registered: 20 Jan 2022

Approval time: 186 (255 working days)

SARS-CoV-2 rS (NVX-CoV2373)

Biocelect Pty Ltd

NUVAXOVID (suspension for injection) is provisionally approved for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

The decision has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

PAXLOVID

Evaluation commenced: 23 Nov 2021

Registration decision: 18 Jan 2022

Date registered: 20 Jan 2022

Approval time: 35 (255 working days)

nirmatrelvir; ritonavir

Pfizer Australia Pty Ltd

PAXLOVID (film-coated tablet) has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death (see section 5.1 Pharmacodynamic properties, clinical trials).

The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the efficacy and safety data from ongoing clinical trials and post-market assessment.

LAGEVRIO provisional registration

Evaluation commenced: 17 Aug 2021

Registration decision: 18 Jan 2022

Date registered: 20 Jan 2022

Approval time: 104 (255 working days)

molnupiravir

Merck Sharp & Dohme (Australia) Pty Ltd

LAGEVRIO (capsule) has provisional approval for the treatment of adults with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk for hospitalisation or death (see section 5.1 Pharmacodynamic properties - clinical trials).

The decision to approve this indication has been made on the basis of the analysis of efficacy and safety data from a Phase 3 trial. Continued approval of this indication depends on additional data.

NUVAXOVID provisional registration

Evaluation commenced: 26 Feb 2021

Registration decision: 19 Jan 2022

Date registered: 20 Jan 2022

Approval time: 186 (255 working days)

SARS-CoV-2 rS (NVX-CoV2373)

Biocelect Pty Ltd

NUVAXOVID (suspension for injection) is provisionally approved for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

The decision has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

PAXLOVID provisional registration

Evaluation commenced: 23 Nov 2021

Registration decision: 18 Jan 2022

Date registered: 20 Jan 2022

Approval time: 35 (255 working days)

nirmatrelvir; ritonavir

Pfizer Australia Pty Ltd

PAXLOVID (film-coated tablet) has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death (see section 5.1 Pharmacodynamic properties, clinical trials).

The decision has been made on the basis of short term efficacy and safety data. Continued approval of this indication depends on the efficacy and safety data from ongoing clinical trials and post-market assessment.

TEPMETKO orphan drug

Evaluation commenced: 31 Aug 2021

Registration decision: 10 Jan 2022

Date registered: 17 Jan 2022

Approval time: 88 (255 working days)

tepotinib hydrochloride monohydrate

Merck Healthcare Pty Ltd

TEPMETKO (film-coated tablet) has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition MET exon 14 skipping alterations.

The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).

VAXNEUVANCE

Evaluation commenced: 1 Feb 2021

Registration decision: 12 Jan 2022

Date registered: 17 Jan 2022

Approval time: 194 (255 working days)

pneumococcal purified capsular polysaccharides

Merck Sharp & Dohme (Australia) Pty Ltd

VAXNEUVANCE (suspension for injection) is indicated for active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F) in adults 18 years of age and older.

VAXNEUVANCE may not prevent disease caused by S. pneumonia> serotypes that are not contained in the vaccine.

The use of VAXNEUVANCE should be guided by official recommendations.

TEPMETKO orphan drugprovisional registration

Evaluation commenced: 31 Aug 2021

Registration decision: 10 Jan 2022

Date registered: 17 Jan 2022

Approval time: 88 (255 working days)

tepotinib hydrochloride monohydrate

Merck Healthcare Pty Ltd

TEPMETKO (film-coated tablet) has provisional approval in Australia for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition MET exon 14 skipping alterations.

The decision to approve this indication has been made on the basis of overall response rate (ORR) and duration of response (DOR). Continued approval of this indication depends on verification and description of benefit in confirmatory trial(s).

VAXNEUVANCE

Evaluation commenced: 1 Feb 2021

Registration decision: 12 Jan 2022

Date registered: 17 Jan 2022

Approval time: 194 (255 working days)

pneumococcal purified capsular polysaccharides

Merck Sharp & Dohme (Australia) Pty Ltd

VAXNEUVANCE (suspension for injection) is indicated for active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F) in adults 18 years of age and older.

VAXNEUVANCE may not prevent disease caused by S. pneumonia serotypes that are not contained in the vaccine.

The use of VAXNEUVANCE should be guided by official recommendations.

LUTETIUM (177lu) CHLORIDE orphan drug

Evaluation commenced: 20 Jan 2021

Registration decision: 8 Dec 2021

Date registered: 11 Jan 2022

Approval time: 189 (255 working days)

lutetium (177lu) chloride

Australian Nuclear Science and Technology Organisation

LUTETIUM (177lu) CHLORIDE (radiochemical solution for injection) is a radiopharmaceutical precursor, and it is not intended for direct use in patients. For the treatment of non resectable or metastatic neuroendocrine tumours (NETS) expressing somatostatin subtype 2 receptors when coupled with a suitable carrier molecule.

LUTETIUM (177lu) CHLORIDE orphan drug

Evaluation commenced: 20 Jan 2021

Registration decision: 8 Dec 2021

Date registered: 11 Jan 2022

Approval time: 189 (255 working days)

lutetium (177lu) chloride

Australian Nuclear Science and Technology Organisation

LUTETIUM (177lu) CHLORIDE (radiochemical solution for injection) is a radiopharmaceutical precursor, and it is not intended for direct use in patients. For the treatment of non resectable or metastatic neuroendocrine tumours (NETS) expressing somatostatin subtype 2 receptors when coupled with a suitable carrier molecule.