Sunday, December 28, 2014

Novartis has announced approval of Cosentyx (secukinumab) for psoriasis and psoriatic arthritis in Japan

The following alert is from our UpdatesPlus service - for a summary of our most recent issue of UpdatesPlus-Psoriasis click here.  This service monitors and analyzes breaking journal articles, clinical trials and R&D news across the inflammatory disease spectrum 
  • Approval has been granted for the treatment of adult psoriasis and psoriatic arthritis patients responding inadequately to systemic therapies (link)
  • This is significant for three reasons
  • Firstly, approval has come in Japan before the EU or the US.  Approval is expected early 2015 in both of these regions
  • Secondly, the approved indication in Japan is more conservative than that recommended in the US and EU, where the FDA AdCom and the CHMP both recommended use in patients who are candidates for systemic or photo therapy
  • Thirdly, Japanese regulators have simultaneously approved Cosentyx for psoriasis and psoriatic arthritis.  In the EU and US, psoriatic arthritis will be filed for as an sBLA in 2015

Comments:  Recommended indications in the US and EU will allow for first line treatment of patients.  This contrasts with the approved indication in Japan, where patients must first be treated with and shown to be insufficiently responsive to systemic therapies.  We presume that this reflects the more conservative nature of Japanese regulators and in addition the general preference of oral over systemic therapeutics in Japan.  The significance of this difference in indications remains to be seen as we expect payers to resist first line treatment with Cosentyx in the US and EU.  Simultaneous approval of psoriasis and psoriatic arthritis in japan is interesting as there are geographic differences in the prevalence of psoriatic arthritis.  Globally 30% of psoriasis patients have psoriatic arthritis;  in Japan however just 3% of psoriasis patients have psoriatic arthritis (source: Novartis press release).  In the US and EU separate psoriasis and psoriatic arthritis studies are required by regulators.  FUTURE 1 and FUTURE 2 studies which specifically enrolled psoriatic arthritis patients are required to support sBLA applications in these regions.   However, because psoriatic arthritis is such an uncommon condition in Japan we understand that indications for both psoriasis and psoriatic arthritis can be approved based on psoriasis studies alone


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