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Eighteen new drugs on Aust horizon
Posted 6 July 2017
Australia can look forward to a plump and exciting bundle of new drugs being approved in the next 12 months if the TGA adopts the FDA's lead and approves the new applications it is likely to be considering right now.
The FDA has approved 23 new drugs in the last six months while the TGA has only approved 14. However, as Australia has an eight-month lag in drug approvals behind the US, the TGA is likely to have a stockpile of applications which is it currently working through.
Pharma in Focus has compiled a list of the18 new drugs most likely to appear on the ARTG in the next 12 months.
Oncology
At the top of the list are the three PD-1 biologics keen to challenge for market share in the fast-growing checkpoint inhibitor space.
First onto the ARTG is expected to be Roche's PD-L1 offering Tecentriq (atezolizumab), approved by the FDA in non-small cell lung cancer in October then bladder cancer in May.
Roche confirmed earlier this year it had filed with the TGA in both indications, with registration expected before the year's end.
Also expected to appear on the ARTG later this year is Merck KGaA and Pfizers' checkpoint inhibitor Bavencio (avelumab), which won FDA-approval in March for metastatic merkel cell carcinoma. The sponsors are expected to seek the same indication in Australia.
AstraZeneca's checkpoint inhibitor Imfinzi (durvalumab) is unlikely to arrive until next year after winning US approval for bladder cancer in May but with AZ confirming it was filing here, Imfinzi is another exciting offering likely to already be in the TGA's burgeoning applications pile.
Oncology remains a strong focus for pharmacos with Tesaro revealing in March it intended to bring its new ovarian cancer drug Zejula (niraparib) to Australia after it was approved in the US. A 2018 ARTG-listing is expected for Zejula.
Lilly's soft tissue carcinoma offering Lartruvo (olaratumab) is also expected to be close to ARTG registration after winning a green light from the FDA last October while Novartis' Kisqali (ribociclib) must also be close to a decision, having been on the PBAC's agenda for PBS-listing consideration this week.
Rheumatology
In other therapeutic areas, rheumatology is a strong focus with Leo Pharma's Siliq (brodalumab) a hot contender for a 2017 ARTG listing in plaque psoriasis while Pfizer's Eucrisa (crisaborole) and Sanofi's Dupixent (dupilumab) should both appear for atopic dermatitis.
Two new drugs which have struggled through the US system but which are seeking registration for rheumatoid arthritis in Australia with a likely 2017 ARTG appearance are Regeneron and Sanofi's biologic Kevzara (sarilumab) and Lilly's Olumiant (baricitinib).
Close to registration must also be Roche's multiple sclerosis biologic Ocrevus (ocrelizumab), which the company confirmed t had filed in both the primary progressive and relapsing forms of the disease in June last year. Ocrevus should appear on the ARTG this quarter.
Amicus Therapies' Galafold (migalastat) is expected to be listed this year in Fabry disease along with Biogen's Spinraza (nusinersen) in spinal muscular dystrophy, which must also be close to market.
MSD's Zinplava (bezlotoxumab) was approved last October in the US for clostridium difficile infection and is therefore also likely to appear on the ARTG this year.
Amgen's hyperparathyroidism drug Parsabiv (etelcalcetide) is among the FDA approvals for 2017 so could also be expected to be in the TGA applications for 2017 along with Novo Nordisk's haemophilia B offering Refixia (nonacog beta pegol).
Shire's Xiidra (lifitegrast) is a long-shot for Australian filing, having struggled to get through the FDA and winning approval a year ago for dry eye disease but would be a welcome addition for a hard-to-treat condition.
Although 2017 is shaping up to be a slow year for Australia approvals, the appearance of these 18 new drugs on the ARTG in the 2017/18 financial year could mark the beginning of an upturn.
Megan Brodie
megan.brodie@lushmedia.com.au
Posted 6 July 2017
Australia can look forward to a plump and exciting bundle of new drugs being approved in the next 12 months if the TGA adopts the FDA's lead and approves the new applications it is likely to be considering right now.
The FDA has approved 23 new drugs in the last six months while the TGA has only approved 14. However, as Australia has an eight-month lag in drug approvals behind the US, the TGA is likely to have a stockpile of applications which is it currently working through.
Pharma in Focus has compiled a list of the18 new drugs most likely to appear on the ARTG in the next 12 months.
Oncology
At the top of the list are the three PD-1 biologics keen to challenge for market share in the fast-growing checkpoint inhibitor space.
First onto the ARTG is expected to be Roche's PD-L1 offering Tecentriq (atezolizumab), approved by the FDA in non-small cell lung cancer in October then bladder cancer in May.
Roche confirmed earlier this year it had filed with the TGA in both indications, with registration expected before the year's end.
Also expected to appear on the ARTG later this year is Merck KGaA and Pfizers' checkpoint inhibitor Bavencio (avelumab), which won FDA-approval in March for metastatic merkel cell carcinoma. The sponsors are expected to seek the same indication in Australia.
AstraZeneca's checkpoint inhibitor Imfinzi (durvalumab) is unlikely to arrive until next year after winning US approval for bladder cancer in May but with AZ confirming it was filing here, Imfinzi is another exciting offering likely to already be in the TGA's burgeoning applications pile.
Oncology remains a strong focus for pharmacos with Tesaro revealing in March it intended to bring its new ovarian cancer drug Zejula (niraparib) to Australia after it was approved in the US. A 2018 ARTG-listing is expected for Zejula.
Lilly's soft tissue carcinoma offering Lartruvo (olaratumab) is also expected to be close to ARTG registration after winning a green light from the FDA last October while Novartis' Kisqali (ribociclib) must also be close to a decision, having been on the PBAC's agenda for PBS-listing consideration this week.
Rheumatology
In other therapeutic areas, rheumatology is a strong focus with Leo Pharma's Siliq (brodalumab) a hot contender for a 2017 ARTG listing in plaque psoriasis while Pfizer's Eucrisa (crisaborole) and Sanofi's Dupixent (dupilumab) should both appear for atopic dermatitis.
Two new drugs which have struggled through the US system but which are seeking registration for rheumatoid arthritis in Australia with a likely 2017 ARTG appearance are Regeneron and Sanofi's biologic Kevzara (sarilumab) and Lilly's Olumiant (baricitinib).
Close to registration must also be Roche's multiple sclerosis biologic Ocrevus (ocrelizumab), which the company confirmed t had filed in both the primary progressive and relapsing forms of the disease in June last year. Ocrevus should appear on the ARTG this quarter.
Amicus Therapies' Galafold (migalastat) is expected to be listed this year in Fabry disease along with Biogen's Spinraza (nusinersen) in spinal muscular dystrophy, which must also be close to market.
MSD's Zinplava (bezlotoxumab) was approved last October in the US for clostridium difficile infection and is therefore also likely to appear on the ARTG this year.
Amgen's hyperparathyroidism drug Parsabiv (etelcalcetide) is among the FDA approvals for 2017 so could also be expected to be in the TGA applications for 2017 along with Novo Nordisk's haemophilia B offering Refixia (nonacog beta pegol).
Shire's Xiidra (lifitegrast) is a long-shot for Australian filing, having struggled to get through the FDA and winning approval a year ago for dry eye disease but would be a welcome addition for a hard-to-treat condition.
Although 2017 is shaping up to be a slow year for Australia approvals, the appearance of these 18 new drugs on the ARTG in the 2017/18 financial year could mark the beginning of an upturn.
Megan Brodie
megan.brodie@lushmedia.com.au
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