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Bumper 2018 in store for ARTG
Posted 15 December 2017
Exclusive Pharma in Focus research has identified the new drugs most likely to appear on the ARTG next year, with more than 20 - so far - promising to kick up regulatory activity in 2018.
TGA activity has already seen an increase in the past six months with 18 new drugs registered compared to 14 in the first half of the year - and promises to grow even busier as the FDA's bumper 2017 impacts Australian registrations.
Past predictions
Out of the eighteen drugs Pharma in Focus predicted would arrive in Australia in the second half of 2017 and the first half of 2018, six were approved, three came under TGA review and five were confirmed by sponsors to have filing in the works.
The remaining four may yet see registration in 2018, with applications for these possibly also under consideration by the TGA or with filings underway.
Included in these are three eczema treatments: Sanofi's Dupixent (dupilumab), Pfizer's Eucrisa (crisaborole) and Leo Pharma's Siliq (brodalumab). Amgen's Parsabiv (etelcalcetide), indicated for hyperparathyroidism, was also on the list.
The drugs which won ARTG registration in the second half of 2017 following US FDA approval on average had a lag of eight and a half months between the jurisdictions' green lights.
What goes around comes down under
The list of additional new drugs approved by the FDA in the second half of 2017 was as packed as the first, with Pharma in Focus identifying 14 as candidates for Australian ARTG registration in 2018.
Five of these have already been confirmed as filed, pointing to likely ARTG registrations in the first half of 2018.
These include Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir) and AbbVie's Maviret (glecaprevir) for hepatitis C, Celgene's Idhifa (enasidenib) for blood cancer, Janssen's Tremfya (guselkumab) for eczema, and STA's Nerlynx (neratinib) for HER2+ breast cancer patients.
Out of the list of drugs marked for ARTG arrival on the back of FDA approval, oncology drugs remain the most dominant class of new therapies.
Aside from Idhifa and Nerlynx, Pfizer's Besponsa (inotuzumab ozogamicin) may be one of the first to reach registration after it won FDA approval for blood cancer in August and clocked up an orphan designation with the TGA last year.
Also expected are Lilly's breast cancer therapy Verzenio (abemaciclib) and Bayer's Aliqopa (copanlisib), which sped through the FDA in four months for third-line follicular lymphoma.
AZ confirmed TGA filing plans for the even speedier Calquence (acalabrutinib), a second-line therapy for mantle cell lymphoma which was under FDA review for just two months before its October accelerated approval.
AZ's asthma medication Fasenra (benralizumab) may also already be before the TGA after it won FDA approval and CHMP recommendation last month with the company stating the drug had regulatory reviews underway in "several other countries".
Another strong candidate for 2018 registration is Roche's Hemlibra (emicizumab), which must be filed before February 2018 if the company wishes to make use of the current priority review designation granted to the haemophilia A treatment.
Also on the priority review list is BioMarin's Brineura (cerliponase alfa), which won FDA approval in April, and has a priority review designation stamped with a May 2018 expiry date.
MSD's anti-infective Prevymis (letermovir) scored US approval in November and has an orphan drug designation in Australia.
Ozempic (semaglutide), the FDA's most recently approved drug, could also be ARTG registered some time in late 2018 after sponsor Novo Nordisk said it had a "keen" interest in bringing the drug to Australian patients.
New therapies set to shake up blood cancer
The FDA's count of new chemical and biological entities did not include CAR-T therapies, a major new class of drugs which have so far notched up two US approvals for Novartis' Kymriah (tisagenlecleucel-T) and Gilead's Kite-acquired Yescarta (axicabtagene ciloleucel).
These drugs are also expected to make an arrival, although Gilead's confirmation of its plans stated discussions were still in "early stage[s]" meaning the drugs will likely not make it onto the ARTG by this time next year.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 15 December 2017
Exclusive Pharma in Focus research has identified the new drugs most likely to appear on the ARTG next year, with more than 20 - so far - promising to kick up regulatory activity in 2018.
TGA activity has already seen an increase in the past six months with 18 new drugs registered compared to 14 in the first half of the year - and promises to grow even busier as the FDA's bumper 2017 impacts Australian registrations.
Past predictions
Out of the eighteen drugs Pharma in Focus predicted would arrive in Australia in the second half of 2017 and the first half of 2018, six were approved, three came under TGA review and five were confirmed by sponsors to have filing in the works.
The remaining four may yet see registration in 2018, with applications for these possibly also under consideration by the TGA or with filings underway.
Included in these are three eczema treatments: Sanofi's Dupixent (dupilumab), Pfizer's Eucrisa (crisaborole) and Leo Pharma's Siliq (brodalumab). Amgen's Parsabiv (etelcalcetide), indicated for hyperparathyroidism, was also on the list.
The drugs which won ARTG registration in the second half of 2017 following US FDA approval on average had a lag of eight and a half months between the jurisdictions' green lights.
What goes around comes down under
The list of additional new drugs approved by the FDA in the second half of 2017 was as packed as the first, with Pharma in Focus identifying 14 as candidates for Australian ARTG registration in 2018.
Five of these have already been confirmed as filed, pointing to likely ARTG registrations in the first half of 2018.
These include Gilead's Vosevi (sofosbuvir/velpatasvir/voxilaprevir) and AbbVie's Maviret (glecaprevir) for hepatitis C, Celgene's Idhifa (enasidenib) for blood cancer, Janssen's Tremfya (guselkumab) for eczema, and STA's Nerlynx (neratinib) for HER2+ breast cancer patients.
Out of the list of drugs marked for ARTG arrival on the back of FDA approval, oncology drugs remain the most dominant class of new therapies.
Aside from Idhifa and Nerlynx, Pfizer's Besponsa (inotuzumab ozogamicin) may be one of the first to reach registration after it won FDA approval for blood cancer in August and clocked up an orphan designation with the TGA last year.
Also expected are Lilly's breast cancer therapy Verzenio (abemaciclib) and Bayer's Aliqopa (copanlisib), which sped through the FDA in four months for third-line follicular lymphoma.
AZ confirmed TGA filing plans for the even speedier Calquence (acalabrutinib), a second-line therapy for mantle cell lymphoma which was under FDA review for just two months before its October accelerated approval.
AZ's asthma medication Fasenra (benralizumab) may also already be before the TGA after it won FDA approval and CHMP recommendation last month with the company stating the drug had regulatory reviews underway in "several other countries".
Another strong candidate for 2018 registration is Roche's Hemlibra (emicizumab), which must be filed before February 2018 if the company wishes to make use of the current priority review designation granted to the haemophilia A treatment.
Also on the priority review list is BioMarin's Brineura (cerliponase alfa), which won FDA approval in April, and has a priority review designation stamped with a May 2018 expiry date.
MSD's anti-infective Prevymis (letermovir) scored US approval in November and has an orphan drug designation in Australia.
Ozempic (semaglutide), the FDA's most recently approved drug, could also be ARTG registered some time in late 2018 after sponsor Novo Nordisk said it had a "keen" interest in bringing the drug to Australian patients.
New therapies set to shake up blood cancer
The FDA's count of new chemical and biological entities did not include CAR-T therapies, a major new class of drugs which have so far notched up two US approvals for Novartis' Kymriah (tisagenlecleucel-T) and Gilead's Kite-acquired Yescarta (axicabtagene ciloleucel).
These drugs are also expected to make an arrival, although Gilead's confirmation of its plans stated discussions were still in "early stage[s]" meaning the drugs will likely not make it onto the ARTG by this time next year.
Yajun Ma
yajun.ma@lushmedia.com.au
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