After FDA rejection, Lilly's ulcerative colitis drug Omvoh picks up support from England's NICE

Even after Eli Lilly missed its first swing at the lucrative U.S. market with ulcerative colitis drug mirikizumab, the company’s launch is gaining steam overseas. 

Friday, England’s National Institute for Health and Care Excellence (NICE) recommended the drug for the treatment of patients with moderate to severe active ulcerative colitis who can’t tolerate—or haven’t responded to—certain other treatments. 

The NICE blessing sets up the drug, known in the U.K. as Omvoh, to be the first IL-23p19 inhibitor to be used in NHS England, Lilly said in a release.

More than 500,000 people in the U.K. suffer from Crohn’s disease or ulcerative colitis. For many, existing treatments don’t work or stop working over time, Sarah Sleet, chief executive of Crohn’s & Colitis UK, said in a statement. 

“Expanding the treatment options for eligible people living with colitis is a promising step forward and we welcome the NICE’s decision to recommend mirikizumab,” Sleet added. 

NICE recommended the drug based on two phase 3 studies in the LUCENT research program.  

In a 12-week induction trial called LUCENT-1, investigators enrolled 1,162 patients and randomized them three-to-one to receive Lilly’s drug or an intravenous placebo every four weeks for a total of 12 weeks.

After the 12 weeks, 24.2% of treated patients achieved clinical remission, compared with 13.3% for those on placebo. 

In the other trial, 544 patients who experienced a clinical response in LUCENT-1 were re-randomized by a two-to-one margin to either receive the drug or subcutaneous placebo injection every four weeks for a maintenance period of 40 weeks. This study was called LUCENT-2. 

After the second trial period, investigators reported that among LUCENT-1 participants who achieved a clinical response after 12 weeks, nearly half achieved clinical remission after the 52-week run of both trials. That compared with around 25% for those on placebo in the maintenance study.

Aside from mirikizumab's recent U.K. win, the drug has scored approvals in Europe and Japan.

But while Lilly's drug picks up steam overseas, it hasn't had as smooth a rollout in the U.S. In April, the FDA handed Lilly a complete response letter citing issues with manufacturing. After receiving the CRL, Lilly resubmitted its application in the second quarter of 2023, according to an Securities and Exchange Commission filing

Besides ulcerative colitis, Lilly is also testing mirikizumab in Crohn’s disease. It's one of several launches that Lilly is counting on for growth this year and beyond.

In a report late last year, analysts with Evaluate predicted the drug could reach $1.2 billion in sales by 2028.