FDA approves Deuruxolitinib (Leqselvi) for Severe Alopecia Areata

The FDA announced yesterday that a third JAK inhibitor received approval for the treatment of severe alopecia areata (more than 50% ) loss.

June 13, 2022 was big day where we welcomed baricitinib (Olumiant) as the first FDA approved drug. Jun 23, 2023 was another key milestone as the second JAK inhibitor Ritlecitinib (LITFULO) received approval. Yesterday marks the approval date for deuruxolitinib (Leqselvi).

Deuruxolitinib is a JAK 1/2 inhibitor – similar to the mechanism of action of baricitinib.  It was the phase 3 THRIVE AA1 and THRIVE AA2 trials that showed that it deuroxolitinib was helpful for alopecia areata. The THRIVE AA1 trial was a randomized, doubled blind placebo controlled trial with 706 patients with severe AA. THRIVE AA2 had 517 patients. Patients in these studies were randomized to either deuruxolitinib 12 mg twice daily, 8 mg twice daily or placebo. By week 24, about 40 % of patients in the 12 mg twice daily group achieved excellent regrowth (defined as a SALT score less than or equal to 20) and 30 % in the 8 mg twice daily group achieved this target.

Longer term data has shown that after 52 weeks of cumulative dosing,  63.6% of patients in the 8 mg twice daily group achieved a SALT score less than 20.

It was a bit of a shocker back in 2023 when news hit the airwaves that the Deuruxolitinib trial was being halted by the FDA because of concerns about pulmonary embolisms (blood clots in the lungs) in patients receive the 12 mg twice daily dose. The 12 mg twice daily dose of deuruxolitinib was en route to being a real blockbuster drug.  I mean the data was super impressive. However, with the concerns about blood clots, further studies of 12 mg twice daily dose were never to be permitted again.  Only the 8 mg dose would be allowed.  

So yesterday the FDA approved the 8 mg twice daily dose. Data at 24 weeks are pretty similar to all the JAKs. However, data at 52 weeks seems to be pretty impressive for deuruxolitinib. If 60% of patients can achieve good regrowth this puts Deuruxolitinib as a potentially better treatment than baricitinib or ritlecitinib.  

We’ll just need to see how things pan out once the drug is launched into the world. We’ll have to follow long term side effects. Cleary the blood clot issue is a bit worrisome even though this did not seem to be an issue at 8 mg twice daily.   Side effects otherwise seem more or less similar to the other JAKS. We’ll need to see what happens in the long term studies. Data from the baricitinib trials show that a small proportion of patients don’t maintain their nice results in year 2 so we’ll just need to see what happens in post marketing and independent studies of Deuruxolitinib. The entire JAK community is closely following if these drugs increase  the risk of cancer, heart disease, blood clots. We know they increase the risk of some infections (ie zoster) but risks are pretty mild.

Welcome to the JAK family deuruxolitinib (Leqselvi)!