FDA Gives Nod To Eli Lilly's First Treatment For Type Of Inflammatory Bowel Disease, To Compete With JNJ, Pfizer, AbbVie

The FDA approved Eli Lilly And Co's LLY Omvoh (mirikizumab-mrkz) for moderately to severely active ulcerative colitis (UC) in adults, marking Lilly's first approved treatment for a type of inflammatory bowel disease.

In April this year, the FDA issued a complete response letter for mirikizumab application for ulcerative colitis, citing issues related to the proposed manufacturing of mirikizumab, with no concerns about the clinical data package, safety, or label for the medicine.

Reuters notes that the drug is among Lilly's potential growth drivers for this decade, alongside tirzepatide for obesity, lebrikizumab for atopic dermatitis or eczema and pirtobrutinib for cancer.

The approval will help Lilly enter a sector where drugs from rivals such as Abbvie Inc ABBV, Pfizer Inc PFE, and Johnson & Johnson JNJ are already vying for a portion of the lucrative multi-billion dollar market.

The approval was based on results from the LUCENT program, which included two Phase 3 trials consisting of one 12-week induction study (UC-1) and one 40-week maintenance study (UC-2) for 52 weeks of continuous treatment. 

Omvoh achieved primary and key secondary endpoints in the trials, including sustained clinical remission in pivotal trials. Omvoh delivered significant improvement in bowel urgency.

Omvoh will be available in the United States in the coming weeks. 

Lilly received approval for Omvoh in Japan and the European Union this year.

Price Action: LLY shares are down 0.27% at $566.56 on the last check Friday.