Extended FDA Review for Lilly/Incyte’s Olumiant (baricitinib) in Rheumatoid Arthritis Delays Market Entry for First Major Competitor to Pfizer’s Xeljanz

And Sanofi-Regeneron’s IL-6 inhibitor, sarilumab, also getting back on track after receiving a Complete Response Letter from the FDA in October 2016. The competition to be the preferred first-line, non-TNF agent in the treatment RA is expected to be fierce in 2017, according to a new report from Spherix Global Insights

Cambridge, Massachusetts. (PRWEB) January 18, 2017 — The competition to be the preferred first-line, non-TNF agent in the treatment RA is expected to be fierce in 2017. According to a new report from Spherix Global Insights (n=100 rheumatologists, fielded in December) about a quarter of the biologic/JAK market is non-TNF agents, with BMS’ Orencia leading the pack for alternative MOAs. However, with the introduction of sarilumab, a new IL-6 that will go head-to-head with Roche’s Actemra and Olumiant, the second JAK to hit the market, the alternative MOA market is likely to expand.

Rheumatologists respond favorably to both new potential market entrants with nearly all respondents anticipating trial of both drugs within the first year of launch. However, both sarilumab and baricitinib are anticipated to be challenged with differentiating from the currently approved agents in the IL-6 and JAK classes, Actemra and Xeljanz. The majority of respondents view the new agents as having similar safety and efficacy profiles as the incumbent agents, a challenge that Janssen/GSK’s sirukumab and Galapagos/Gilead’s filgotinib will also face.

The advantage may go to Olumiant for several reasons with patient demand and preference for an oral agent, particularly one with once-daily dosing, being key drivers. Xeljanz is a good proxy here, with 51% of respondents indicating that their overall Xeljanz use has increased since the launch of the XR once-daily formulation.

For sarilumab, a promising opportunity is the intended increase in IL-6 use in the near term, a trend it can hopefully ride. However, Roche’s strategy for expanded indications for Actemra and the flexibility of IV or SC administration, taken in combination with the extensive post-marketing experience, are likely to be major barriers to sarilumab adoption. For both new entrants, in common with their predecessors, the ability to leapfrog Orencia and to drive switching from patients with suboptimal response to TNF agents will be a big factor in future success. Furthermore, in this market, any opportunity to gain competitive advantage in the market access arena is critical, trumping clinical considerations in many cases.

Respondent’s advice to the Olumiant Launch Team? “Avoid Xeljanz’s mistakes” and “Make sure to have an excellent patient assistance program in place and adequate samples available at launch” reflect much of the advice from survey respondents who urge Lilly to come to market with a favorable reimbursement positioning compared to Xeljanz.

Spherix’s coverage of the RA market will continue with a Q1 update on the trends in the RA space in addition to a large-scale chart audit of more than 1,000 biologic/JAK-treated RA patients recently switched between brands.

To view media coverage of this report, click here.

About Spherix Global Insights
Spherix Global Insights is a business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.

For more information contact:
Lynn Price, Immunology Franchise Head
Email: info@spherixglobalinsights.com
Phone: 1-800-661-0571