New immunotherapies march ahead
Following approval in Europe this week, Novartis’ Cosentyx (secukinumab) has now been given the go-ahead in the US for the treatment of moderate-to-severe plaque psoriasis in adults.
Cosentyx is the first approved psoriasis medication to selectively bind to interleukin-17A (IL-17A) and inhibit its interaction with the IL-17 receptor and looks set to rival current treatments, including anti-tumour necrosis factor therapies (anti-TNFs).
The approval is based on the efficacy and safety outcomes from 10 phase II and III studies, including over 3,990 patients with moderate-to-severe plaque psoriasis, which demonstrated that Cosentyx resulted in clear or almost clear skin in the majority of patients and had an acceptable safety profile.
In phase III studies, Cosentyx met all primary and key secondary endpoints, including Psoriasis Area and Severity Index (PASI) 75 and 90 and Investigator’s Global Assessment modified 2011 (IGA) 0/1 responses, showing significant skin clearance at week 12.
Psoriasis affects 7.5 million Americans, nearly 35 per cent of whom have moderate-to-severe forms.
Randy Beranek, president and CEO of the National Psoriasis Foundation explained, “What works to treat one person’s psoriasis may not work for another, so we’re excited that there is a new option on the market.”
First Enbrel biosimilar under EMA review
In Europe, Samsung Bioepis’ biosimilar candidate for Enbrel (etanercept), SB4, has cleared the first regulatory hurdle, with acceptance for Marketing Authorisation review by the European Medicines Agency. The application was based on results from a phase III clinical trial in patients with moderate-to-severe rheumatoid arthritis (RA).
If approved, SB4 could be used for all the same indications as Enbrel in Europe, including moderate-to-severe RA, certain forms of juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis.
If authorised, SB4 will be commercialised in Europe by Biogen Idec.
Samsung Bioepis will seek additional regulatory approvals in territories worldwide. The company was established in 2012 and is part of the Samsung group.
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