Janssen seeks FDA approval for IL-23 blockbuster hopeful guselkumab

Janssen will hope for an FDA approval for a med it has touted as a future blockbuster

J&J’s biotech arm has submitted its application to the FDA for its experimental med guselkumab in moderate to severe plaque psoriasis.

Janssen said in statement this morning that the app for its mAb, which targets interleukin (IL)-23 – a protein which has been shown to play a key role in the development of immune-mediated inflammatory disease – is based on a series of recent mid-to-late-stage data .

This includes Phase III figures posted last month from the Voyage 1 test, which showed the drug performing well against placebo and AbbVie’s major blockbuster Humira (adalimumab).


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Back in March, rival Eli Lilly won FDA approval for its IL-17A anti-inflammatory ixekizumab, a blockbuster hopeful that will compete against a new wave of rival therapies for psoriasis, and which is now being sold as Taltz.

It followed in the footsteps of Cosentyx (secukinumab), the first IL-17A drug to hit the market after Novartis gained a pioneering approval. In January, the Swiss major also added two new approvals for their drug, for psoriatic arthritis and ankylosing spondylitis, as it guns for the $5 billion in peak projected sales.

Janssen execs have remained bullish about the blockbuster potential for guselkumab, believing it too can gain blockbuster revenue. 

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