Jockeying with a slew of next-generation treatments, Novartis' ($NVS) new anti-inflammatory drug succeeded in two Phase III trials on patients with psoriatic arthritis, stoking the company's hopes of snagging significant market share once it wins approval.
The treatment, secukinumab, is an injected antibody that blocks interleukin-17A, a protein that plays a major role in inflammation. In two trials involving more than 1,000 patients combined, Novartis' drug met its primary and secondary endpoints, beating out placebo in relieving symptoms of psoriatic arthritis (PsA), preventing joint damage and maintaining clear skin, the company said. Secukinumab was well-tolerated in both studies, notching a safety profile in line with earlier trials, Novartis said.
Now the Swiss drugmaker is plotting to file for FDA and European approvals in PsA next year. The company already has pending secukinumab applications in psoriasis, for which it expects to win approval by early 2015.
Novartis believes its antibody can provide a valuable alternative to the standard of care, blockbuster anti-TNF treatments like Enbrel and Humira, pointing out that patient response to such drugs tends to diminish over time.
|Novartis Global Head of Development Vasant Narasimhan|
"Effective new therapies are urgently needed for newly PsA-diagnosed patients and for nearly half of PsA patients who are dissatisfied with or not responding to their current treatments," Novartis Global Head of Development Vasant Narasimhan said in a statement.
But Novartis will have to worry about more than just the standard of care if and when it launches secukinumab for psoriasis and PsA. As of this week, Celgene's ($CELG) oral Otezla is approved for both indications, and Amgen ($AMGN) and AstraZeneca ($AZN) are working up an IL-17A inhibitor called brodalumab that has charted excellent Phase III results in both diseases. Meanwhile, Eli Lilly ($LLY) is in the midst of Phase III with the similar ixekizumab, trailed by Merck's ($MRK) MK-3222 and Johnson & Johnson's ($JNJ) guselkumab.
Beyond its top two indications, secukinumab is also in development for ankylosing spondylitis and rheumatoid arthritis, with filings for those conditions expected in 2015. If Novartis can pull off all four approvals for its antibody, analysts have speculated that the drug could clear $1 billion in annual sales by 2020.
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