Spherix Global Insights

July 13, 2022

Jyseleca and Zeposia: The Future of Ulcerative Colitis in the EU?

Spherix’s Eric John reveals preliminary data on two new oral agents and how they are impacting the ulcerative colitis market in the European Union.

 

The Difficulties of Approving Therapies in Gastroenterology

Did you know that ulcerative colitis patients are often the last patients to receive access to therapies approved for other immune indications? There is actually a set progression when it comes to drug approvals. Therapies for other immune conditions like psoriasis or rheumatoid arthritis are often approved first. This occurs because inflammatory bowel disease is more difficult to treat, especially from an efficacy perspective.

For those that suffer from this condition, it can be extremely frustrating to wait for access to much needed relief. However, things are looking up for the UC patient community, particularly in Europe, where two new oral, small molecule agents were approved in November of last year.

I have been following the ulcerative colitis market for some time now and wanted to dive into the last six months of data to understand how these new agents are impacting the market and helping those with the disease. In the midst of summer and enjoying time off for vacations and new adventures, it’s easy to forget how difficult it may be for those suffering from diseases like UC to enjoy those same life experiences. My hope is that the availability of these oral therapies opens the door to an improved quality of life for UC patients across Europe and throughout the globe.

 

How is UC Treated? 

The standard of care for moderate to severe UC is still dominated by injectable or infusion biologic therapy. While injectable therapies often prove efficacious, the lack of a selective pathway and the mode of administration can decrease patient adherence and increase overall patient burden. Prior to the approvals of Gilead and Galapagos’ Jyseleca and BMS’ Zeposia last November, Pfizer’s Xeljanz was the only oral option commercially available to treat the disease in the EU.

It was interesting to see the EMA approve both agents within a week of each other this past November, especially given the FDA’s decision to issue a CRL for filgotinib (Jyseleca) in the US for the treatment of rheumatoid arthritis (leading to a halt in clinical development for the agent in UC). This gave me the unique opportunity to track their subsequent performance at the same time and give perspective on what could have been in the US market (where only Zeposia got the FDA nod).

 

Uptake and Initial Data 

Slightly over one-quarter of gastroenterologists in the EU are currently prescribers of the two new orals. So far, both agents have seen very similar uptake, performing particularly well in Germany, and each with an overall patient share of 2% across the EU5 (France, Germany, Italy, Spain, and the UK). Where Jyseleca and Zeposia lag the most is in Spain and Italy, with 1% patient share in both countries.

While these oral treatments have only been on the market for about six months, there is a clear profile of current prescribers. Three-quarters of physicians who are prescribers of either Jyseleca or Zeposia have prescribed both agents. Additional analysis indicates that physicians who prescribe Xeljanz are being targeted as potential prescribers for both new oral therapies.

Jyseleca and Zeposia have proven to perform similarly on metrics such as levels of prescribing by line of therapy, severity, and monotherapy versus combination use, as well as methods for prescribing (e.g. insurance coverage, compassionate use, clinical trials).

 

Jyseleca vs. Zeposia: Clinical Performance 

While both agents are neck and neck in many of these areas, Jyseleca is perceived as a stronger clinical performer. Our data shows that 28% of physicians who prescribe Zeposia indicated they were considering prescribing Jyseleca, while only 14% of physicians who prescribed Jyseleca indicated they were considering Zeposia as well. Some of the slight favoritism towards Jyseleca could be due to the manufacturer, Galapagos, being EU-based, while Zeposia’s manufacturer, BMS, is headquartered in the US.

I speculate that Jyseleca will have slightly more success in the EU since it possesses some distinct advantages over Zeposia. First, not only will physicians likely favor an EU-based company, it may also be harder for BMS to promote Zeposia as this is the company’s first gastroenterology biologic launch in the EU. Second, Jyseleca is not being overtly penalized (so far) for being a JAK inhibitor and carrying the baggage of warnings on clotting and malignancies.

Further answers on the outcomes of Jyseleca competing with Zeposia are coming soon as Spherix is poised to release its annual EU RealWorld Dynamix™ switching report, a patient chart audit of recently switched UC and CD patients receiving advanced therapy (biologics, JAKs, S1Ps). Be sure to check back for more answers on these exciting new UC treatment options by the end of July.