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

2023-09-22

临床结果临床3期上市批准

After a National Institute for Health and Care Excellence decision, certain patients with ulcerative colitis in the U.K. will soon have access to a new therapy from Eli Lilly.

Even aftNational Institute for Health and Care Excellenceive U.S. market with ulcerative culcerative colitiszumab, the company’s launch is gaining steam overseas.Eli Lilly

Friday, EngElidLillytional Institute for Health and Care Excellence (NICE) reculcerative colitisfor thmirikizumab 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.active ulcerative colitis

More than 500,000 people in the U.K. suffer from Crohn’s Omvohse or ulcerative cIL-23p19 inhibitor IL-23p19For many, existing treatments don’t woLilly stop working over time, Sarah Sleet, chief executive of Crohn’s & Colitis UK, said in a statement.

“Expanding the treatment options for eligible peoCrohn’s disease colulcerative colitisg 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 LUCcolitisearch program.mirikizumab

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.Lilly

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 Lmirikizumab 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 ulLillyive colitis, Lilly is also testing mirikizumab in Crohn’s disease. It's one of several launchFDAthat LilLilly counting on for growth this year and beyond.Lilly