JAK inhibitor PDUFA dates extended again as safety review continues; Stemson secures $15M to cure hair loss
Two more supplemental new drug applications have been delayed again — this time from AbbVie, and the partners Eli Lilly and Incyte — as the FDA continues its ongoing safety assessment of the class of drugs known as JAK inhibitors.
The agency is continuing to evaluate Pfizer’s failed post-marketing trial, known as ORAL Surveillance, which showed those who received either a low or high dose of its JAK inhibitor Xeljanz experienced more major cardiovascular events — such as stroke and heart attack — than those on Humira or Enbrel. They also had higher rates of cancer, with Pfizer failing to hit non-inferiority on both primary endpoints.
AbbVie said Friday that no formal regulatory action has been taken on its sNDAs for Rinvoq in atopic dermatitis, psoriatic arthritis or ankylosing spondylitis, after those supplements were officially delayed by three months in April. Similarly, after a 3-month delay for Lilly and Incyte’s Olumiant in April, FDA again delayed its decision on Friday for Olumiant as a treatment for adults with moderate to severe atopic dermatitis.
Stemson makes headway with hair loss cure
Stemson Therapeutics on Thursday closed a DCVC Bio-led $15 million Series A to advance its potential cure for hair loss.
Genoa Ventures, AbbVie Ventures and other investors joined in the round. Stemson is working to restore hair growth with a cell regeneration tech that uses the patient’s own cells to generate new hair follicles.
“The Series A funding will help us optimize our solution for human skin structure and environment so we can go into our first human clinical trial with high confidence for a positive outcome,” CEO and co-founder Geoff Hamilton said in a statement.