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CHMP recommendations may flag Aust filings
Posted 14 November 2017
Six new drugs and four extensions were recommended by Europe's CHMP this week, with some of the positive opinions signalling potential Australian filings to follow.
MSD's Prevymis (letermovir) was recommended by the committee for cytomegalovirus reactivation in patients receivng immunosuppressants after stem cell transplant, a week after US approval was handed down.
Its regulatory wins also strengthens the case for an Australian filing, which could occur by next July given the drug's TGA designation as an orphan drug, approved under the old rules, will expire by then.
AZ's Fasenra (benralizumab) was also recommended as an add-on treatment of severe eosinophilic asthma.
In its statement on the EU panel opinion, AZ said it had regulatory reviews underway in "several other countries" outside of the US and Japan for the drug, suggesting Australian filing could be a possibility. Decisions for these jurisdictions are expected in the first half of 2018.
An approval could put Fasenra on track to compete with GSK's eosinophilic asthma treatment Nucala (mepolizumab) which was PBS listed at the start of this year.
Roche's multiple sclerosis drug Ocrevus (ocrelizumab) was also recommended by the CHMP, as well as a new form of budesonide, Jorveza, marketed by Dr Falk Pharma and indicated for the treatment of rare disease eosinophilic oesophagitis.
Ronding off the recommended new therapies were Baxalta's haemophilia A therapy Adynovi (rurioctocog) and Endoceutic's Intrarosa (prasterone) for vulvovaginal atrophy.
Four extensions recommended
Takeda's Adcetris (brentuximab vedotin) won panel support for a fourth indication treating CD30+ cutaneous T-cell lymphoma (CTCL) in a second-line usage setting. The drug was approved in the US for the same indication a few days ago.
The company has since told Pharma in Focus it is "considering its position in relation to seeking expanded indications for Adcetris for patients in Australia", where it is ARTG registered for CD30+ Hodgkin's lymphoma.
Meanwhile paediatric extensions were given backing for the following drugs: Gilead's HIV therapy Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), Amgen's Nplate (romiplostim) for immune thrombocytopenic purpura, and Orkambi (lumacaftor/ivacaftor), Vertex's cystic fibrosis drug.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 14 November 2017
Six new drugs and four extensions were recommended by Europe's CHMP this week, with some of the positive opinions signalling potential Australian filings to follow.
MSD's Prevymis (letermovir) was recommended by the committee for cytomegalovirus reactivation in patients receivng immunosuppressants after stem cell transplant, a week after US approval was handed down.
Its regulatory wins also strengthens the case for an Australian filing, which could occur by next July given the drug's TGA designation as an orphan drug, approved under the old rules, will expire by then.
AZ's Fasenra (benralizumab) was also recommended as an add-on treatment of severe eosinophilic asthma.
In its statement on the EU panel opinion, AZ said it had regulatory reviews underway in "several other countries" outside of the US and Japan for the drug, suggesting Australian filing could be a possibility. Decisions for these jurisdictions are expected in the first half of 2018.
An approval could put Fasenra on track to compete with GSK's eosinophilic asthma treatment Nucala (mepolizumab) which was PBS listed at the start of this year.
Roche's multiple sclerosis drug Ocrevus (ocrelizumab) was also recommended by the CHMP, as well as a new form of budesonide, Jorveza, marketed by Dr Falk Pharma and indicated for the treatment of rare disease eosinophilic oesophagitis.
Ronding off the recommended new therapies were Baxalta's haemophilia A therapy Adynovi (rurioctocog) and Endoceutic's Intrarosa (prasterone) for vulvovaginal atrophy.
Four extensions recommended
Takeda's Adcetris (brentuximab vedotin) won panel support for a fourth indication treating CD30+ cutaneous T-cell lymphoma (CTCL) in a second-line usage setting. The drug was approved in the US for the same indication a few days ago.
The company has since told Pharma in Focus it is "considering its position in relation to seeking expanded indications for Adcetris for patients in Australia", where it is ARTG registered for CD30+ Hodgkin's lymphoma.
Meanwhile paediatric extensions were given backing for the following drugs: Gilead's HIV therapy Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), Amgen's Nplate (romiplostim) for immune thrombocytopenic purpura, and Orkambi (lumacaftor/ivacaftor), Vertex's cystic fibrosis drug.
Yajun Ma
yajun.ma@lushmedia.com.au
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