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Challenging agenda for July PBAC
Posted 27 April 2017
The PBAC will consider over 60 submissions and reports at its next meeting including a string of major submissions on drugs yet to be registered in Australia.
The as yet unapproved drugs include AbbVie's so far unbranded HCV medicine gelcaprevir/pibrentasvir, which the company has submitted for chronic hepatitis C infection regardless of genotype.
At the same meeting, Gilead will resubmit Epclusa (sofosbuvir/velpatasvir) with a request that "the PBAC review its advice that sofosbuvir with velpatasvir should be treated as interchangeable on an individual patient basis with other direct-acting antiviral regimens". Eplcusa was recommended for hepatitis C PBS listing in November 2016. At the time Gilead noted the PBAC had ruled on interchangeability despite the sponsor not raising the issue in its submission and said there are groups of patients that "cannot be treated with all the drugs determined to be interchangeable".
The PBAC will also see Novartis yet-to-be-approved Kisqali (ribociclib), which is being submitted for use in combination with letrozole to treat HR+, HER2- advanced or metastatic breast cancer in patients who are not premenopausal; Roche's new multiple sclerosis treatment Ocrevus (ocrelizumab) is also on the list.
Eli Lilly's new rheumatoid arthritis drug Olumiant (barcitinib), just rejected for market approval in the US, rounds out the unapproved group. The US rejection was a surprise to the company and the market with the FDA calling on Lilly and co-developer Incyte to provide additional clinical data on safety and dose.
Resubmissions
The committee will also see nine resubmissions for drugs it has rejected on previous occasions.
They include Novo Nordisk's Victoza (liraglutide), one of three type 2 diabetes submissions that include AstraZeneca's unique combination Qtern (saxagliptin/dapagliflozin).
Cancer resubmissions will be prominent with Mundipharma retunring with Folotyn (pralatrexate) for second line use against peripheral T-cell lymphoma, Amgen bringing back Kyprolis (carfilzomib) for second line use in multiple myeloma and Ipsen bringing back Somatuline Autogel (lanreotide) for non-functional gastroentero-pancreatic neuroendocrine tumours.
Other resubmissions include Vertex's Orkambi (lumacaftor/ivacaftor) and Pharmaxis' Bronchitol (mannitol) in cystic fibrosis and Eisai's Fycompa (perampanel) in epilepsy.
The full agenda, sorted according to submission type and indication, will be published in this afternoon's Pharma in Focus.
Nick Lush
nick.lush@lushmedia.com.au
Posted 27 April 2017
The PBAC will consider over 60 submissions and reports at its next meeting including a string of major submissions on drugs yet to be registered in Australia.
The as yet unapproved drugs include AbbVie's so far unbranded HCV medicine gelcaprevir/pibrentasvir, which the company has submitted for chronic hepatitis C infection regardless of genotype.
At the same meeting, Gilead will resubmit Epclusa (sofosbuvir/velpatasvir) with a request that "the PBAC review its advice that sofosbuvir with velpatasvir should be treated as interchangeable on an individual patient basis with other direct-acting antiviral regimens". Eplcusa was recommended for hepatitis C PBS listing in November 2016. At the time Gilead noted the PBAC had ruled on interchangeability despite the sponsor not raising the issue in its submission and said there are groups of patients that "cannot be treated with all the drugs determined to be interchangeable".
The PBAC will also see Novartis yet-to-be-approved Kisqali (ribociclib), which is being submitted for use in combination with letrozole to treat HR+, HER2- advanced or metastatic breast cancer in patients who are not premenopausal; Roche's new multiple sclerosis treatment Ocrevus (ocrelizumab) is also on the list.
Eli Lilly's new rheumatoid arthritis drug Olumiant (barcitinib), just rejected for market approval in the US, rounds out the unapproved group. The US rejection was a surprise to the company and the market with the FDA calling on Lilly and co-developer Incyte to provide additional clinical data on safety and dose.
Resubmissions
The committee will also see nine resubmissions for drugs it has rejected on previous occasions.
They include Novo Nordisk's Victoza (liraglutide), one of three type 2 diabetes submissions that include AstraZeneca's unique combination Qtern (saxagliptin/dapagliflozin).
Cancer resubmissions will be prominent with Mundipharma retunring with Folotyn (pralatrexate) for second line use against peripheral T-cell lymphoma, Amgen bringing back Kyprolis (carfilzomib) for second line use in multiple myeloma and Ipsen bringing back Somatuline Autogel (lanreotide) for non-functional gastroentero-pancreatic neuroendocrine tumours.
Other resubmissions include Vertex's Orkambi (lumacaftor/ivacaftor) and Pharmaxis' Bronchitol (mannitol) in cystic fibrosis and Eisai's Fycompa (perampanel) in epilepsy.
The full agenda, sorted according to submission type and indication, will be published in this afternoon's Pharma in Focus.
Nick Lush
nick.lush@lushmedia.com.au
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