The FDA has responded to Eli Lilly’s Biologic License Application (BLA) for mirikizumab — an ulcerative colitis drug with blockbuster potential — with a complete response letter, the company announced this week.
The agency’s letter stated concerns regarding the proposed manufacturing process for the drug, but did not raise any issues regarding the medicine's clinical data package, safety or labeling.
Mirikizumab, an anti-IL-23 mAb, was originally developed for psoriasis but achieved statistically superior rates of clinical remission at 12 weeks compared to patients taking a placebo in phase 3 trials in ulcerative colitis. The drug will become the first and only anti-IL23p19 treatment for people with ulcerative colitis if Lilly can get the approval.
The treatment has already been approved by the Japanese regulatory authority as a first-in-class medication for treating moderately to severely active ulcerative colitis in adults, and the EMA's Committee for Medicinal Products for Human Use has issued a favorable opinion on its use in adults with the same condition who did not respond to either conventional therapy or previous biologic treatment.
If eventually approved, mirikizumab is expected to join the biologics blockbusters club, with projected sales reaching a total of $14.6 billion by the end of 2038. Along with other potential blockbusters, mirikizumab's approval was one of the most anticipated from the agency this year.
Lilly is "working diligently with the FDA" and hopes to get the nod to launch mirikizumab in the U.S. as soon as possible.
