Saturday, January 10, 2015

2015 promises to be a good year for psoriatic arthritis and ankylosing spondylitis drug development

We are pleased to announce the release of January's issue of UpdatesPlus-Spondyloarthropathy.  This 74 slide report identifies and analyzes emerging information in areas of psoriatic arthritis, ankylosing spondylitis and non-radiographic spondyloarthropathy.  Information includes papers, new trials, clinical data, conference presentations and company releases.  The report also presents a fully up to date landscape and clinical trial overview

UpdatesPlus-Spondyloarthropathy is a regular report, and is part of our rheumatology and dermatology collection.  Reports are accompanied by ad hoc e-mail alerts providing near real time analysis of key breaking events.  For further information please contact fiona.watts@leaddiscovery.co.uk or see our UpdatesPlus product brochure

Current market leaders in the Spondyloarthropathy segment include Humira, Remicade and Enbrel. Little new activity has been reported around these products although of note, the first biosimilar version of Humira has been launched in India.  Elsewhere Remicade continues to come under biosimilar threat, not least through Remsima filing in the US and the USPO's rejection of one of J&J's Remicade patents.  Remsima is expected to launch in major EU markets this quarter

As a relatively new member of the TNFi class, Simponi continues to grow healthily. Continued read out of long-term psoriatic arthritis (GO-REVEAL) and ankylosing spondylitis (GO-RAISE) data is expected to contribute to clinical confidence given impressive drug survival and durable efficacy.  J&J has also submitted an sBLA for non-radiographic spondyloarthropathy

Most recent noise however is around Otezla (apremilast, PDE4 inhibitor from Celgene) and Cosentyx (secukinumab, IL-17 mAb from Novartis)

Otezla was first approved by the FDA for lead indication, psoriatic arthritis in March 2014.  The FDA has now also approved Otezla for psoriasis.  This was followed by the EMA's CHMP recommending approval for both indications in Europe.  At the same time the FDA AdCom and CHMP have approved Cosentyx for psoriasis

In terms of data flow, ACR 2014 in Boston was a key platform for Celgene with more than 10 psoriatic arthritis presentations delivered.  These reinforced the durability of Otezla  and the apparent accumulation of efficacy with long-term treatment. New 52wk PALACE 4 data (DMARD na├»ve) were presented.  Overall Otezla has performed well clinically in terms of nail and joint structure improvement.  Drug survival is good, responses are durable and drug safety is to date excellent; the main question mark hangs over efficacy in terms of skin lesions

Cosentyx looks promising across the rheumatology and dermatology spectra. This biologic is set to become the first to market IL-17 mAb for psoriasis having been recommended for FDA and EMA approval at the end of 2014.  Japanese regulators have however trumped western agencies, approved Cosentyx for both psoriasis and psoriatic arthritis.  Cosentyx promises to be a field changer exhibiting high levels of efficacy and good safety. Data were reported in detail for the first time at ACR from FUTURE 1 and FUTURE 2, pivotal psoriatic arthritis studies of Cosentyx.  ACR20 and PASI90 improvement was impressive.  Effects on joint structure appears at least as good as current options while resolution of skin lesions appears competitive.  As reported for psoriasis, adverse events are limited and we expect Novartis' EU and US regulatory filings for psoriatic arthritis (probably early/mid 2015) to be successful

Cosentyx is also performing well in ankylosing spondylitis. MEASURE 2, which enrolled AS patients closed for enrolment H2 2014.  MEASURE 1, also in AS, completed earlier in 2014 and Novartis announced in October that both studies had met their primary endpoint. MEASURE 1 was presented at ACR 2014 and reported impressive ASAS20 rates


For our full report  please contact fiona.watts@leaddiscovery.co.uk 

1 Comments:

Blogger medya balkon said...

Cosentyx has been approved for a.s. yesterday in usa by fda (not sure of the day, maybe the day before yesterday)

7:23 AM  

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