OLUMIANT® (baricitinib), a novel drug from Eli Lilly & Company and Incyte, has been introduced for the treatment of individuals with severe alopecia areata (AA).
The proposed drug has yet to be approved by European regulators.
If approved, Olumiant will be the first centrally sanctioned oral medicine and the first JAK inhibitor in the European Union to treat severe AA patients.
The European Commission is expected to make a decision in the coming months.
A favorable opinion was granted based on the safety and efficacy of Olumiant in 1,200 patients with severe AA who participated in the Phase III BRAVE-AA1 and BRAVE-AA2 clinical studies.
In the BRAVE-AA1 and BRAVE-AA2 studies, one out of every three people who got 4mg Olumiant achieved 80 percent or higher scalp hair covering, compared to one out of every 20 and one out of every 50 participants who received placebo.
In comparison to those in the placebo arm, therapy with 4mg Olumiant resulted in full regrowth or regrowth with minor gaps in eyebrow and eyelash hair. This was for one in three patients at 36 weeks.
In the Phase III BRAVE-AA clinical trial, which also looked at Olumiant's safety profile, no new safety signals were observed.
Olumiant® (Baricitinib) is a once-daily oral Janus kinase (JAK) inhibitor that targets enzymes that interfere with the inflammatory cascade.
Its primary ingredient, baricitinib, inhibits the action of enzymes involved in immunological processes that cause inflammation.
JAKs are intracellular enzymes that impact hematopoiesis and immune cell activity by transmitting signals derived from cytokine or growth factor-receptor interactions on the cellular membrane.