AbbVie's DLBCL Drug EPKINLY, Crohn's Disease Drug RINVOQ Get Health Canada Approval

(RTTNews) - AbbVie (ABBV) announced Tuesday that Health Canada has approved EPKINLY (epcoritamab injection/epcoritamab for injection) to treat Relapsed or Refractory Diffuse Large B-Cell Lymphoma or DLBCL, as well as RINVOQ (upadacitinib) to treat moderately to severely active Crohn's Disease.

EPKINLY has received the authorization with conditions as the first and only subcutaneous bispecific antibody to treat adult patients with Relapsed or Refractory DLBCL. EPKINLY has been issued marketing authorization with conditions, pending the results of clinical trials to verify its clinical benefit. The drug is being co-developed by AbbVie and Genmab.

EPKINLY's authorization is based on the positive results of the EPCORE NHL-1 clinical trial, in which it delivered an overall response rate of 63 percent, a complete response rate of 39 percent and median duration of response of 12 months in heavily pretreated R/R DLBCL patients.

Further, RINVOQ (upadacitinib, 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]), an oral, once-daily selective and reversible JAK inhibitor, has been approved for the treatment of adults with moderately to severely active Crohn's disease.

Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain.

The approval is supported by data from three Phase 3 clinical trials, including two induction studies and one maintenance study. Across all three studies, significantly more patients treated with upadacitinib achieved the co-primary endpoints of clinical remission and endoscopic response.

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