ARTICLE | Regulation

May 19 Quick Takes: AbbVie wins accelerated approval of bispecific for DLBCL

Plus: Another setback for Intercept’s NASH candidate, and updates from Krystal, Moderna

May 19, 2023 10:51 PM UTC

Patients with third-line or later diffuse large B cell lymphoma will have a new treatment option: bispecific antibody Epkinly epcoritamab from AbbVie Inc. (NYSE:ABBV), which gained accelerated approval Friday. The product, a T cell engager, targets CD3 and CD20 using DuoBody technology from Genmab A/S (CSE:GMAB; NASDAQ:GMAB); it has shown best-in-class potential. AbbVie views Epkinly as a late-2020s growth driver as the pharma seeks to rebound from the loss of patent exclusivity for Humira adalimumab.

Three years after Intercept Pharmaceuticals Inc. (NASDAQ:ICPT) was initially denied accelerated approval of obeticholic acid (OCA) to treat non-alcoholic steatohepatitis, an FDA advisory panel has voted against accelerated approval of OCA for the same indication. On Friday, FDA’s Gastrointestinal Drugs Advisory Committee voted 15-1 to defer the approval decision until the clinical outcomes data needed for a full approval become available. The committee also voted 12-2 with two abstentions that the benefits of the bile acid analogue did not outweigh its risks. “It’s impossible to ensure a good risk-benefit profile based on this surrogate endpoint data; we need to see the full clinical outcomes,” said the University of Washington’s James Floyd. OCA’s PDUFA date is set for June 22. ...