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Janssen's Tremfya under TGA consideration
Posted 9 November 2017
A scheduling delegate's decision on Janssen's psoriasis drug Tremfya (guselkumab) has revealed it has been submitted for ARTG registration while the company also prepares to enrol local patients in a new trial program testing the drug in an expanded arthritis indication.
Tremfya appeared in the delegate's October final decisions with a date of 1 October for scheduling on the poisons standard, a decision confirmed by the health department to be "in relation to an ARTG application".
Janssen confirmed the drug had been filed but did not disclose potential registration dates to Pharma in Focus however the TGA's regulatory evaluation process usually takes 12 months. The scheduling decision has already been implemented.
Among its global regulatory filings for Tremfya in the plaque psoriasis indication, only its US application has been granted approval although Janssen is wasting no time in attempting to build up the treatment scope of the biologic.
It has plans to launch two new phase 3 trials examining Tremfya as a treatment for first- and second-line psoriatic arthritis with six Australian sites expected to participate in the global program, adding local evidence to data which the company hopes will strengthen the drug's credentials as it enters a crowded immunology space.
The drug has already attempted to make its case against rivals with part of the data submitted to the FDA for its psoriasis approval including a head-to-head component with AbbVie's huge blockbuster Humira (adalimumab), showing Tremfya had significantly improved skin clarity in 70 per cent of patients compared to Humira's 40 per cent.
Meanwhile, other companies in the space have attempted to strengthen supporting data for their own approved immunology medicines in preparation for the new entrants coming into the market.
Novartis recently reported positive results for its widely approved Cosentyx (secukinumab), showing its biologic inhibited joint damage in patients with psoriatic arthritis and inhibited damage in ankylosing spondylitis patients' spines.
The older drug may not only have to defend against Tremfya but also Lilly's Taltz (ixekizumab) which, like Janssen's drug, has already been approved in plaque psoriasis but is being tested in arthritis in clinical trials.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 9 November 2017
A scheduling delegate's decision on Janssen's psoriasis drug Tremfya (guselkumab) has revealed it has been submitted for ARTG registration while the company also prepares to enrol local patients in a new trial program testing the drug in an expanded arthritis indication.
Tremfya appeared in the delegate's October final decisions with a date of 1 October for scheduling on the poisons standard, a decision confirmed by the health department to be "in relation to an ARTG application".
Janssen confirmed the drug had been filed but did not disclose potential registration dates to Pharma in Focus however the TGA's regulatory evaluation process usually takes 12 months. The scheduling decision has already been implemented.
Among its global regulatory filings for Tremfya in the plaque psoriasis indication, only its US application has been granted approval although Janssen is wasting no time in attempting to build up the treatment scope of the biologic.
It has plans to launch two new phase 3 trials examining Tremfya as a treatment for first- and second-line psoriatic arthritis with six Australian sites expected to participate in the global program, adding local evidence to data which the company hopes will strengthen the drug's credentials as it enters a crowded immunology space.
The drug has already attempted to make its case against rivals with part of the data submitted to the FDA for its psoriasis approval including a head-to-head component with AbbVie's huge blockbuster Humira (adalimumab), showing Tremfya had significantly improved skin clarity in 70 per cent of patients compared to Humira's 40 per cent.
Meanwhile, other companies in the space have attempted to strengthen supporting data for their own approved immunology medicines in preparation for the new entrants coming into the market.
Novartis recently reported positive results for its widely approved Cosentyx (secukinumab), showing its biologic inhibited joint damage in patients with psoriatic arthritis and inhibited damage in ankylosing spondylitis patients' spines.
The older drug may not only have to defend against Tremfya but also Lilly's Taltz (ixekizumab) which, like Janssen's drug, has already been approved in plaque psoriasis but is being tested in arthritis in clinical trials.
Yajun Ma
yajun.ma@lushmedia.com.au
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