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Amgen decision on brodalumab unsettles anti-IL-17 class

Move made following data found linking the drug to suicidal thoughts

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Amgen's decision to hand back rights to brodalumab to AstraZeneca (AZ) on safety grounds has raised a question mark over the entire IL-17 inhibitor class.

The move has been taken on the back of data linking brodalumab use to suicidal thoughts and - while there is no suggestion yet this is a class effect - the negative sentiment could affect the uptake of rival IL-17 inhibitors from Novartis and Eli Lilly.

Amgen said it had taken the decision "based on events of suicidal ideation and behaviour in the brodalumab program, which … likely would necessitate restrictive labelling," while AZ said it would take a decision on the future of the drug "based on further review of the data."

The issue seems to have emerged out of left field, with Amgen's head of R&D Sean Harper suggesting the company spotted the safety signal during preparations for regulatory filings. Four other antibodies subject to AZ and Amgen's 2012 partnership are unaffected by the decision.

Brodalumab was beaten to market by Novartis' IL-17 inhibitor Cosentyx (secukinumab) - approved for psoriasis in the US, Europe and Japan in January - and is in a race for second place with Lilly's ixekizumab.  

Despite missing out on pole position AZ's drug had been tipped to make significant headway in psoriasis and other indications such as rheumatoid arthritis, with some analysts predicting peak sales of $2bn or more, although AZ had been more conservative with projections of $500m to $1.5bn.

The big question now is whether the side effect is real and - if so - is related to the mechanism of action of the drug. AZ has claimed in the past that its molecule has a slightly different profile to its rivals, blocking the binding of several IL-17 subtypes to the receptor for the cytokine, so it could be compound specific. 

If there is any fall-out from the brodalumab finding, in the near-term it will likely benefit Johnson & Johnson's IL-12 and IL-23 inhibitor Stelara (ustekinumab), a $2bn product considered the most vulnerable to competition from the IL-17 inhibitor class. While the IL-17 inhibitors have topped Stelara in terms of efficacy, J&J and BMS can point to long-term safety data.

Analysts at Deutsche Bank and Barclays issued research notes indicating there is no evidence that Cosentyx is affected by the same issue.

However, with several new antibodies coming through the pipeline for psoriasis and other inflammatory disorders, clinicians may be tempted to choose another option over an IL-17-targeting drug. Celgene's new oral therapy Otezla (apremilast) is one candidate, along with J&J's Stelara follow-up guselkumab and anti-IL-23 antibodies from Merck & Co/Sun Pharma and J&J/Morphosys.

The news also affects Kyowa Hakko Kirin, which has rights to brodalumab in Japan, but at the time of writing the Japanese firm had not made any public statement about the revelation. 

Article by
Phil Taylor

26th May 2015

From: Regulatory

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