Eli Lilly and Co (NYSE:LLY) has announced that its Omvoh drug has been approved by the US Food and Drug Administration (FDA) to treat types of inflammatory bowel disease.
Following a third-phase 12-week clinical trial, in which Omvoh prompted responses in 65% of patients and remission in 24%, Eli Lilly announced the approval on Thursday.
“I see many people with ulcerative colitis who previously tried other biologic treatments, and they are still searching for an effective option that can offer rapid and lasting improvements," commented Bruce Sands, M.D., M.S., Dr. Burrill B. Crohn professor of Medicine and chief of the Dr. Henry D. Janowitz Division of gastroenterology, Icahn School of Medicine at Mount Sinai.
"Today's approval represents a novel scientific advancement.”.
Omvoh is Eli’s first treatment to be approved for moderately to severely active ulcerative colitis in adults, the company said.
The drug often offers relief for stool frequency, rectal bleeding and bowel urgency, Sands added, even in patients who have previously tried other treatments.
“Bowel urgency is one of the most disruptive symptoms for patients with ulcerative colitis,” Crohn's & Colitis Foundation president Michael Osso commented.
"Today's approval [...] offers new hope for those who have tried other therapies and still find themselves making accommodations for the uncertainty of bowel urgency-related accidents.”