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New migraine drug on horizon
Posted 21 September 2018
With a win in the US this week and marketing applications submitted to both the EMA and TGA, Teva's new migraine drug Ajovy could become available in Australia next year.
The FDA approved the drug under priority review based on two placebo-controlled phase III studies in which patients experienced a reduction in monthly migraine days during a 12-week period.
Ajovy's dosing options of either one injection of 225 mg administered monthly or a 675 mg injection administered quarterly distinguishes the drug from existing treatments.
The option to be administered in an office by a healthcare profession or at home by a caregiver every three months ultimately reduces the total amount of time spent receiving the drug and visits required.
The Teva drug is racing to catch up with rival drug, Novartis' Aimovig, which was approved by the TGA in July and is up for consideration by PBAC in November.
Aimovig can be self-administered but requires monthly dosing.
Also looking to file in Australia is Lilly's as yet unnamed biologic galcanezumab for the treatment of chronic migraines, believed to be on a list of drugs Lilly hopes to bring to Australia.
Allergan's Botox is PBS-listed for migraine.
Tiffany Walker
Posted 21 September 2018
With a win in the US this week and marketing applications submitted to both the EMA and TGA, Teva's new migraine drug Ajovy could become available in Australia next year.
The FDA approved the drug under priority review based on two placebo-controlled phase III studies in which patients experienced a reduction in monthly migraine days during a 12-week period.
Ajovy's dosing options of either one injection of 225 mg administered monthly or a 675 mg injection administered quarterly distinguishes the drug from existing treatments.
The option to be administered in an office by a healthcare profession or at home by a caregiver every three months ultimately reduces the total amount of time spent receiving the drug and visits required.
The Teva drug is racing to catch up with rival drug, Novartis' Aimovig, which was approved by the TGA in July and is up for consideration by PBAC in November.
Aimovig can be self-administered but requires monthly dosing.
Also looking to file in Australia is Lilly's as yet unnamed biologic galcanezumab for the treatment of chronic migraines, believed to be on a list of drugs Lilly hopes to bring to Australia.
Allergan's Botox is PBS-listed for migraine.
Tiffany Walker
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