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Pipeline Monitor
New COPD, cancer wins at EMA
Posted 24 November 2017
The EMA has followed through on a number of CHMP positively recommended treatments this week, including GSK's COPD triplet and a Tesaro cancer drug, which have now become available in the jurisdiction.
The agency approved GSK's Trelegy Ellipta (vilanterol/umeclidinium/fluticasone), a therapy combining three drugs in a once-a-day closed single inhaler, which offers more convenient administration of drugs previously inhaled separately.
It was granted CHMP positive recommendation in September and has found its way to the PBAC agenda for its out-of-session December meeting although an ARTG registration has yet to be made.
Tesaro's Zejula (niraparib) was also approved for relapsed ovarian cancer regardless of BRCA or biomarker status, making it the first PARP inhbitor approved in Europe for the indication according to Tesaro's company statement.
AZ's PARP inhibitor Lynparza (olaparib) is indicated only for BRCA-mutated forms of the cancer while Clovis' Rubraca (rucaparib) is still in filing stages in Europe.
The EMA's approval was based on a phase 3 trial which showed Zejula increased progression free survival in patients with or without germline BRCA mutations compared to the control arm.
Janssen's Zytiga (abiraterone) had a submission for first-line use in hormone-sensitive prostate cancer approved by the regulatory body as well, following an October CHMP recommendation, while Novartis' Tasinga (nilotinib) won an extended paediatric indication to treat Ph+ chronic myeloid leukaemia.
Janssen pitches Darzalex for first-line
Janssen has filed to expand use of Darzalex (daratumumab) in the EU, aiming to get approval of the drug for a new combination use to treat adult patients with newly diagnosed multiple myeloma and who are ineligble for autologous stem cell transplant.
The filing is the first time Janssen has applied for first-line setting for the biologic and will see it combined with the company's Velcade (bortezomib), prednisone and chemotherapy drug melphalan.
The submission was made with data from the phase 3 ALCYONE study which has a results release date set for the Annual Meeting of the American Society of Haematology in December.
Novo plots obesity expansion
Novo has outlined plans to trial its diabetes II candidate semaglutide in a large scale study for obesity as the company capitalises on positive weight data found in earlier trials of the drug.
The trial, testing a once-weekly injection, will enroll around 4500 patients and occur over 68 weeks as the company puts significant resources behind the potential new indication.
Semaglutide was filed to the FDA for type II diabetes last December and is expected to have a decision announced in the next few months, with an approval considered likely after an FDA panel voted unanimously in support of the drug.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 24 November 2017
The EMA has followed through on a number of CHMP positively recommended treatments this week, including GSK's COPD triplet and a Tesaro cancer drug, which have now become available in the jurisdiction.
The agency approved GSK's Trelegy Ellipta (vilanterol/umeclidinium/fluticasone), a therapy combining three drugs in a once-a-day closed single inhaler, which offers more convenient administration of drugs previously inhaled separately.
It was granted CHMP positive recommendation in September and has found its way to the PBAC agenda for its out-of-session December meeting although an ARTG registration has yet to be made.
Tesaro's Zejula (niraparib) was also approved for relapsed ovarian cancer regardless of BRCA or biomarker status, making it the first PARP inhbitor approved in Europe for the indication according to Tesaro's company statement.
AZ's PARP inhibitor Lynparza (olaparib) is indicated only for BRCA-mutated forms of the cancer while Clovis' Rubraca (rucaparib) is still in filing stages in Europe.
The EMA's approval was based on a phase 3 trial which showed Zejula increased progression free survival in patients with or without germline BRCA mutations compared to the control arm.
Janssen's Zytiga (abiraterone) had a submission for first-line use in hormone-sensitive prostate cancer approved by the regulatory body as well, following an October CHMP recommendation, while Novartis' Tasinga (nilotinib) won an extended paediatric indication to treat Ph+ chronic myeloid leukaemia.
Janssen pitches Darzalex for first-line
Janssen has filed to expand use of Darzalex (daratumumab) in the EU, aiming to get approval of the drug for a new combination use to treat adult patients with newly diagnosed multiple myeloma and who are ineligble for autologous stem cell transplant.
The filing is the first time Janssen has applied for first-line setting for the biologic and will see it combined with the company's Velcade (bortezomib), prednisone and chemotherapy drug melphalan.
The submission was made with data from the phase 3 ALCYONE study which has a results release date set for the Annual Meeting of the American Society of Haematology in December.
Novo plots obesity expansion
Novo has outlined plans to trial its diabetes II candidate semaglutide in a large scale study for obesity as the company capitalises on positive weight data found in earlier trials of the drug.
The trial, testing a once-weekly injection, will enroll around 4500 patients and occur over 68 weeks as the company puts significant resources behind the potential new indication.
Semaglutide was filed to the FDA for type II diabetes last December and is expected to have a decision announced in the next few months, with an approval considered likely after an FDA panel voted unanimously in support of the drug.
Yajun Ma
yajun.ma@lushmedia.com.au
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