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TGA schedules new migraine biologic
Posted 31 January 2018
A number of new therapies, including Novartis and Amgens' biologic erenumab and GSK's shingles vaccine, have been scheduled by the TGA.
The regulator released its delegate's final scheduling decisions for January 2018 with a list of 22 drugs, some of which are not yet registered.
Novartis and Amgen's erenumab was one of the yet-to-registered drugs on the list. It was submitted to the delegate by the TGA and will be included in the Poisons Standard in Schedule 4 in February.
Erenumab is not yet approved in any jurisdiction but is part of a new class of biologic therapies, that includes Lilly's galcanezumab and Teva's fremanezumab, coming down the pipeline and indicated for migraine.
Novartis, which has exclusive rights to the drug outside Japan, recently announced updated phase 3 results showing it achieved at least a 50 per cent reduction of migraine days versus placebo.
Also on the scheduling list was a new zoster virus vaccine, most likely GSK's Shingrix, as the company has confirmed it has been submitted to the TGA for regulatory review.
Data from clinical trials showed the newer vaccine bested Sequirus' NIP-listed Zostavax, providing 90 per cent effectiveness over four years compared to 70 per cent with the older vaccine.
Other scheduled medicines included MSD's letermovir, indicated as a prophylaxis of cytomegalovirus, and Array's melanoma combination therapy, binimetinib/encorafenib. Neither therapy has been registered.
Yajun Ma
Posted 31 January 2018
A number of new therapies, including Novartis and Amgens' biologic erenumab and GSK's shingles vaccine, have been scheduled by the TGA.
The regulator released its delegate's final scheduling decisions for January 2018 with a list of 22 drugs, some of which are not yet registered.
Novartis and Amgen's erenumab was one of the yet-to-registered drugs on the list. It was submitted to the delegate by the TGA and will be included in the Poisons Standard in Schedule 4 in February.
Erenumab is not yet approved in any jurisdiction but is part of a new class of biologic therapies, that includes Lilly's galcanezumab and Teva's fremanezumab, coming down the pipeline and indicated for migraine.
Novartis, which has exclusive rights to the drug outside Japan, recently announced updated phase 3 results showing it achieved at least a 50 per cent reduction of migraine days versus placebo.
Also on the scheduling list was a new zoster virus vaccine, most likely GSK's Shingrix, as the company has confirmed it has been submitted to the TGA for regulatory review.
Data from clinical trials showed the newer vaccine bested Sequirus' NIP-listed Zostavax, providing 90 per cent effectiveness over four years compared to 70 per cent with the older vaccine.
Other scheduled medicines included MSD's letermovir, indicated as a prophylaxis of cytomegalovirus, and Array's melanoma combination therapy, binimetinib/encorafenib. Neither therapy has been registered.
Yajun Ma
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