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The FDA approved mirikizumab (Omvoh) for the treatment of adults with moderately to severely active ulcerative colitis, on Thursday.

The injectable drug selectively binds the p19 subunit of interleukin (IL)-23; it's the first product with this mechanism of action to be approved for ulcerative colitis. Other agents targeting IL-23 such as ustekinumab (Stelara) are already available for ulcerative colitis, but they are less selective. Another anti-p19 drug, risankizumab (Skyrizi), was by its manufacturer, AbbVie.

Lilly had hoped to secure the OK months ago, but the because of issues with mirikizumab's manufacturing.

Lilly's LUCENT trials underpinned the approval. These showed clinical remission rates of 24% after a 12-week induction period, compared with 15% in a placebo group; the less stringent clinical response rates were 65% and 24%, respectively. With maintenance therapy for those patients achieving clinical responses initially, 50% remained in remission at week 40, versus 25% with placebo. Specific ulcerative colitis symptoms such as rectal bleeding and fecal urgency showed rapid improvement for most patients, Lilly said.

"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," said Bruce Sands, MD, of the Icahn School of Medicine at Mount Sinai in New York City. This "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."

While calls for the drug to be used for moderate to severe disease, it does not specify that patients must have failed or proved intolerant to other medications such as 5-aminosalicylates that typically are used initially.

It also lists several warnings (not boxed, however) and cautions: mirikizumab "may increase the risk of infection," and it should not be given if patients have a "clinically important" ongoing infection. Live-virus vaccines should be avoided. Also, patients should be tested for tuberculosis before starting mirikizumab, and liver enzymes and bilirubin should be checked periodically for at least the first 6 months of treatment.

The most common adverse reactions (reported in at least 2% of patients at a higher frequency than placebo) associated with mirikizumab were upper respiratory infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection.

The product can be administered subcutaneously or by IV infusion. The recommended dosing plan is to start with IV infusion at 300 mg, given every 4 weeks for three doses, then subcutaneous injections of 200 mg every 4 weeks.

The company indicated that mirikizumab should reach pharmacy shelves "in the coming weeks."

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