Secukinumab getting ready for FDA approval

[Fred]

We've been reporting the progress of Secukinumab for a while now on Psoriasis Club, and soon it looks like we will be reporting it has gained FDA approval for the treatment of psoriasis.

Secukinumab is a first in class, fully human, monoclonal IgG1κ IL17A antibody that selectively binds to the pro inflammatory cytokine interleukin 17A (IL17A) and inhibits
its interaction with the IL17 receptor. IL17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses and plays a role in the pathogenesis of plaque psoriasis.

On the 20th October, FDA advisers will be voting whether to recommend it for full approval. And are due to give a final decision on by January 2015.

The general summery of the FDA Briefing Document states:

Quote:

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The currently available data support a favorable benefit risk assessment for the use of secukinumab for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. No major safety issues associated with secukinumab use have been identified to date.

Source: NO LINKS ALLOWED

More on secukinumab:
Novartis AIN457 (secukinumab) data shows relief for 81% of psoriasis patients
Secukinumab V Stelara
Secukinumab V Enbrel

*If anyone wants to see the full FDA Briefing Document I have it on PDF so let me know via PM.

[Fred]

UPDATE:

The Dermatologic and Ophthalmic Drugs Advisory Committee today voted 7-0 to support approval. The FDA don't have to follow their recommendations, but they usually do.

The final decision is still expected January.