Physician Views: If approved by the FDA will Lilly’s Olumiant still be competitive in RA?

If the FDA approves Eli Lilly's Olumiant (baricitinib) for rheumatoid arthritis, there is a risk the JAK inhibitor will limp over the regulatory finish line in the US, warn analysts. In April, an advisory committee recommended approval of a 2mg dose of Olumiant, but voted against a 4mg dose due to benefit/risk concerns.

This makes for an intriguing situation, as key opinion leaders recently interviewed by FirstWord believe Olumiant should be approved by the FDA; and those based in Europe - where it was approved last year - view it as a useful addition to the treatment landscape.

Whether or not a protracted route to market in the US will meaningfully tarnish Olumiant's commercial profile remains to be seen. Adoption of Eli Lilly's drug will be determined in part also by existing physician comfort levels with Pfizer's first-in-class JAK inhibitor Xeljanz; a product available as both a twice-daily 5mg dose and once-daily 11mg dose and unburdened by thrombosis safety concerns.

To get a better view on how Olumiant may be utilised (if it is approved by the FDA), we are snap-polling US-based rheumatologists with the following questions…

Last month, an FDA advisory committee voted 10-5 in favour of approving a 2mg dose of the JAK inhibitor baricitinib (proposed brand name Olumiant) for the treatment of adults with moderately-to-severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Simultaneously, the panel voted by the same margin against recommending approval of a 4mg dose; it unanimously supported the efficacy of the higher dose, but did not recommend its approval based on safety and benefit/risk profiles. Concerns were raised over the risk of thrombosis linked to the 4mg dose.

Assuming that the FDA follows the committee's recommendation (i.e. approves 2mg dose; does not approve 4mg dose), would your perception of baricitinib be adversely affected?

Yes

No

Assuming that the FDA follows the committee's recommendation (i.e. approves 2mg dose; does not approve 4mg dose), would you expect to prescribe baricitinib once available?

No

Yes - infrequently

Yes - frequently

Yes - very frequently

How comfortable are you from an efficacy perspective with Xeljanz (tofacitinib) as a treatment option for moderately-to-severely active rheumatoid arthritis?

Not comfortable

Moderately comfortable

Very comfortable

How comfortable are you from a safety perspective with Xeljanz as a treatment option for moderately-to-severely active rheumatoid arthritis?

Not comfortable

Moderately comfortable

Very comfortable

Taking into account the views of the FDA's AdCom panellists and your perception of baricitinib and Xeljanz, if baricitinib 2mg is approved by the FDA, would lower pricing represent a viable strategy to drive adoption of baricitinib at the expense of Xeljanz?

Yes

No

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions. Note: FirstWord Polls are powered by Medefield MedePolls, a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties and over 100 markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

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