Concert persuades FDA to keep breakthrough tag for alopecia therapy despite Lilly's arrival

Concert Pharmaceuticals managed to keep hold of the breakthrough tag for its alopecia areata therapy, even though the approval of Eli Lilly’s rival gave the FDA second thoughts.

Concert secured the breakthrough-therapy status back in 2020 as it raced deuruxolitinib to become the first janus kinase (JAK) inhibitor approved for moderate to severe alopecia areata. However, in June 2022, Lilly and Incyte’s JAK inhibitor Olumiant was approved for the moderate version of the disease, causing the FDA to look again at Concert’s tag.

The agency asked the biotech to submit additional clinical data—including from two phase 3 trials that showed the candidate induced hair regrowth—as part of a justification for why deuruxolitinib still deserved to be considered a breakthrough therapy. The FDA grants breakthrough designation to therapies that treat a serious or life-threatening condition where preliminary clinical evidence suggests it may offer substantial improvement over available treatments.

It seems the agency was happy with what it received from Concert, as the biotech announced today that it received the all-clear for deuruxolitinib’s tag to remain in place. The therapy also previously received fast-track designation from the regulator.

Deuruxolitinib is an oral JAK1/2 inhibitor designed to treat alopecia areata, an autoimmune disease that causes hair loss and has limited treatment options. Concert completed a phase 3 evaluation in moderate to severe alopecia and found 41.5% of people had at least 80% scalp hair coverage after taking a high dose. Concert has also been conducting two long-term extension studies of deuruxolitinib in North America and Europe while assessing the candidate in other indications. 

Today’s news will be received gratefully at Sun Pharmaceutical, which announced last month that it’s acquiring Concert for $576 million. Sun plans to stick to Concert’s schedule of submitting deuruxolitinib to the FDA for approval in the first half of 2023.