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Novartis has become the first player to bring to market an interleukin-17A inhibitor, most recently announcing on Monday that the European Commission approved Cosentyx for the treatment of moderate-to-severe plaque psoriasis. Approval in the US market for the same indication is also expected in the near future.
With regulators on both sides of the Atlantic providing positive assessment of Cosentyx prior to full approval, a green-light for the product comes as little surprise. Indeed, focus among analysts in recent months has switched to the commercial opportunity for Cosentyx.
Analysts at UBS argued in December that among Novartis investors, Cosentyx continues to fly under the radar despite its near-term launch (a status shaped by high levels of focus on the approval and launch of LCZ696 for heart failure, they add). They note, however, that Novartis could have two potential blockbuster launches on its hands in 2015 if both Cosentyx and LCZ696 live up to potential.
Key data for Cosentyx appears to be the Phase IIIb study results top-lined by Novartis in December which demonstrated superiority versus Johnson & Johnsons IL-12/IL-23 inhibitor Stelara. Stelara has emerged as the new standard of care among biologic therapies indicated to treat moderate-to-severe psoriasis thanks to better efficacy, cleaner safety and more convenient dosing relative to the heavily entrenched anti-TNF agents (i.e. Humira, Enbrel, Remicade). As such, Stelara has emerged as one of the industrys fastest growing drugs (ViewPoints: New data may vault Novartis Cosentyx into lead among competitors vying for Stelaras crown)).
Cosentyx is not the only IL-17A inhibitor to have demonstrated superiority versus Stelara, with this feat matched by Amgen and AstraZenecas co-developed competitor drug brodalumab. Crucially, however, analysts currently estimate that Novartis has an approximate 12-month head-start (and thus IL-17A inhibitor monopoly position) over brodalumab, which is not due to be filed until the second half of 2015. A third IL-17A inhibitor, Eli Lillys ixekizumab, is in Phase III development, but has not been studied head-to-head versus Stelara; a decision that is likely to weaken its commercial profile, at least initially.
In the psoriasis setting (the IL-17A inhibitors are being studied across additional indications), the next 12 months could therefore be critical in shaping the trajectory of secukinumab and the class as a whole.
In response to EU approval, we are polling EU5 and US-based dermatologists with the following questions
- How aware are you of secukinumab?
- How impressive do you consider Phase III data for secukinumab to be?
- Excluding the consideration of price, how would you describe your anticipated usage levels of secukinumab in its first 12 months of availability among newly diagnosed patients with moderate-to-severe plaque psoriasis for whom treatment with a biologic is appropriate?
- Excluding the consideration of price, how would you describe your anticipated usage levels of secukinumab in its first 12 months of availability among patients with moderate-to-severe plaque psoriasis who are being switched from another biologic therapy?
- How important a role will your experience with current biologics and the established safety profiles of these products play in limiting and/or slowing uptake of secukinumab and other products in the IL-17a class?
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