Amgen and AstraZeneca are set to file psoriasis therapy brodalumab for approval next year after posting positive data from a third and final phase III trial involving the drug.
In the AMAGINE-2 trial, brodalumab given every two weeks was found to be more effective in clearing skin lesions in patients with moderate-to-severe plaque psoriasis than Johnson & Johnson’s Stelara (ustekinumab).
Amgen and AZ’s drug achieved total skin clearance – in other words a 100 rating on the Psoriasis Area Severity Index (PASI) scale – in between 25.7% and 44.4% of patients, depending on the dose used. Stelara achieved PASI 100 scores in 21.7% of patients, while for placebo the rate was 0.6%.
The new data reinforces earlier clinical trials of the drug – AMAGINE-1 and AMAGINE-3 – which respectively showed that the drug was more effective than placebo and Stelara in psoriasis.
Brodalumab acts by blocking the activity of the pro-inflammatory cytokine interleukin-17 (IL-17), while Stelara is an IL-12/IL-23 blocker. The latter drug has emerged as a major new treatment for psoriasis, and is on track to achieve sales of almost $2bn this year.
Amgen and AZ are competing with Eli Lilly and Novartis to bring an anti-IL17 drug to market for psoriasis, as well as potential follow-up indications such as psoriatic arthritis and asthma.
Novartis is in the lead with its Cosentyx (secukinumab), having already bagged a Committee for Medicinal Products for Human Use (CHMP) positive opinion for the drug last week as well being recommended for approval by an FDA advisory committee. Meanwhile, Lilly’s ixekizumab is in late-stage clinical testing.
AZ claims brodalumab is the only investigational treatment in development that inhibits inflammatory signalling “by blocking the binding of several IL-17 cytokines (A, F and A/F) to the receptor.”
Meanwhile, additional competition for the IL-17 inhibitors will come from Celgene’s already-approved oral therapy Otezla (apremilast) – which is also predicted to become a blockbuster – and J&J’s Stelara follow-up guselkumab. Pfizer’s Xeljanz (tofacitinib), which is already approved for rheumatoid arthritis, could also be a rival with a potential filing in psoriasis next year.
All told, sales in major markets of drugs to treat psoriasis are tipped for rapid growth over the next decade, increasing from $6.6bn in 2013 to $10.7bn in 2023 according to data from Decision Resources. Earlier this year, AZ said it expected brodalumab to have peak sales potential of between $500m and $1.5bn.