ARTICLE | Regulation

June 13 Quick Takes: Lilly approval marks FDA’s first for a systemic alopecia drug

Plus durability questions for CRISPR Therapeutic’s CAR T, and updates from Merck, Beigene, Sanofi and more 

June 14, 2022 12:29 AM UTC

Eli Lilly and Co. (NYSE:LLY) received FDA approval for its Olumiant baricitinib oral tablets to treat adult patients with severe alopecia areata. The approval was based on two Phase III trials in patients who had at least 50% scalp hair loss for more than six months, as measured by the Severity of Alopecia Tool. The primary endpoint was the proportion of patients who achieved at least 80% scalp hair coverage at week 36, with the high dose leading to 35% and 32% in the two trials, vs. 5% and 3% in the placebo arms. Olumiant was first approved in 2018 to treat moderate-to-severe active rheumatoid arthritis. The therapy has a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. It is also approved to treat COVID-19 in certain hospitalized adults.

Allogeneic CAR T cell therapy CTX130 from CRISPR Therapeutics AG (NASDAQ:CRSP) is maintaining the early response rates reported last month as additional T cell lymphoma patients are added to the Phase I/II COBALT-LYM study, but the therapy is running into the same durability concerns as other allogeneic CAR Ts. Across 10 patients in the dose-escalation study’s second and third dose levels, who had received a median of four prior therapies, objective response rate was 70%, complete response rate was 30%, and 90% achieved disease control. Among the three patients who achieved a complete response, two cases progressed before month three and one is ongoing at three months. Recent data from allogeneic CAR T data from Caribou Biosciences Inc. (NASDAQ:CRBU), whose CB-010 led to high response rates in lymphoma patients, also raised durability questions...

Access The Full Article