Eli Lilly enters crowded ulcerative colitis market with delayed FDA approval for Omvoh

Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too.

With a new FDA approval, Lilly’s mirikizumab has become the first IL-23 inhibitor to enter the crowded ulcerative colitis field, which is already occupied by biologic drugs from AbbVie, Johnson & Johnson and Takeda.

Thursday’s approval allows mirikizumab, to be marketed under the brand Omvoh, to be used first as an infusion and then as a subcutaneous injection to treat moderately to severely active ulcerative colitis. It comes after the FDA rejected the drug in April over manufacturing problems uncovered during a preapproval inspection.

Before the delayed FDA go-ahead, Omvoh had already won approvals in Japan and Europe earlier this year. It also picked up a reimbursement recommendation in England.

In two trials coded LUCENT, Omvoh delivered positive results as an induction and maintenance therapy for previously treated patients with ulcerative colitis.

After 12 weeks of induction treatment, 24% of patients on Omvoh achieved clinical remission, which compared with 15% for those on a placebo. During the maintenance phase, 66% of Omvoh takers who had achieved remission at 12 weeks stayed in remission through one year of treatment. Only 40% of patients in the placebo group could say the same.

Clinical remission and clinical response are standard endpoints in ulcerative colitis trials. For the LUCENT program, investigators also measured bowel urgency based on an 11-point scorecard developed by Lilly.

Among patients who achieved clinical response in the induction study, patients receiving Omvoh experienced an average 3.8-point reduction in bowel urgency at one year, versus 2.74 for the placebo group.

“Omvoh addresses key symptoms that matter most to patients and represents our patient-centric approach to treatment innovation,” Patrik Jonsson, president of Lilly Immunology and chief customer officer of the Lilly group, said in a statement Thursday.

Many ulcerative colitis patients who have tried other biologic drugs are still searching for an effective treatment, Bruce Sands, M.D., from the Icahn School of Medicine at Mount Sinai and lead investigator of the LUCENT program, said in a statement. “Today's approval represents a novel scientific advancement, providing a treatment that may offer relief from three key symptoms—stool frequency, rectal bleeding and bowel urgency—regardless of past biologic use.”

By selectively targeting IL-23, Omvoh is viewed as a better therapy than J&J’s blockbuster Stelara, which targets both IL-12 and IL-23. With multiple indications, Stelara ginned up $8.1 billion sales during the first nine months of 2023. Other biologics in the ulcerative colitis market include AbbVie’s Humira and Takeda’s Entyvio.

Meanwhile, another IL-23 inhibitor is getting closer to launching in ulcerative colitis.

AbbVie in August filed its fast-growing Skyrizi in ulcerative colitis to both the FDA and the European Medicines Agency based on positive phase 3 readouts. What’s more, the AbbVie IL-23 inhibitor recently topped Stelara in a head-to-head Crohn’s disease trial.

For its part, Lilly this month unveiled positive results for Omvoh in Crohn’s disease, where the drug beat placebo on both clinical remission and endoscopic response. However, Omvoh didn’t show superiority over Stelara when it came to endoscopic response at one year of treatment.

With Omvoh, Lilly is expanding its inflammatory disease presence, which is already built on IL-17 plaque psoriasis antibody Taltz and JAK inhibitor Olumiant. In June, Lilly shelled out $2.4 billion upfront to acquire Dice Therapeutics, gaining an oral IL-17 inhibitor that’s in phase 2 development for psoriasis.

But in another embarrassing FDA rejection that’s not related to a drug’s clinical profile, the FDA earlier this month turned down Lilly’s atopic dermatitis candidate lebrikizumab over deficiencies at a contract manufacturer. The IL-13 inhibitor is billed as a potential competitor to Sanofi’s blockbuster Dupixent.

Omvoh and lebrikizumab are two of four drug launches that Lilly expects to drive growth this year and beyond. BTK blood cancer drug Jaypirca already got its FDA nod in January, and Alzheimer’s disease treatment donanemab could receive a decision by the end of the year after the FDA snubbed Lilly’s accelerated approval bid in January.