Lilly moves Crohn's drug into phase 3, faces safety setback in Japan


Eli Lilly has had a mixed few days, posting promising trial results for mid-stage Crohn’s disease drug mirikizumab, undercutting a key insulin from Sanofi in the US, but facing safety concerns over a new breast cancer drug in Japan.

First, the good news for the Indianapolis-based pharma, from the SERENITY phase 2 study in severely active Crohn’s disease.

The trial showed patients treated with the drug mirikizumab saw significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared with placebo, and a maintenance phase of the study is ongoing.

Lotus Mallbris, vice president of immunology development at Lilly, said that results seen against endoscopic response, endoscopic remission, and patient-reported outcomes supported further exploration in late-stage trials.

Lotus Mallbris

Mallbris said: “Physicians want objective signs of improvement to be able to convey to patients that they are getting better, and data from this study suggest mirikizumab may address this need.

“We look forward to initiating phase 3 trials to further evaluate mirikizumab's benefit-risk profile for the treatment of Crohn's disease.”

Mirikizumab is an investigational monoclonal antibody that binds to the p19 subunit of interleukin 23. It is being studied for the treatment of immune diseases, including psoriasis, ulcerative colitis and Crohn's disease.

Piling pressure on Sanofi

Eli Lilly has already marketed a cheaper biosimilar to Sanofi’s long-lasting Lantus (insulin glargine), stealing significant market share in the US.

Now Lilly is up to the same trick with Sanofi’s rapid acting insulin Humalog (insulin lispro), pricing its new near-copy at half the list price of its rival.

Lilly’s Insulin Lispro injection will have a list price of $137.35 and $265.20 for a pack of five pens.

People who are most likely to benefit are Humalog users who are on Medicare Part D, people with high-deductible health plans and the uninsured.

Pharmacists will be able to substitute Eli Lilly’s insulin Lispro for Sanofi’s Humalog.

Concerns over Verzenio in Japan

However there were worries for Lilly in Japan, after it was reported that the country’s health regulator has warned over the safety of its key breast cancer drug Verzenio.

The Japan Times reported that 14 patients taking the drug developed serious lung disease, and of those, at least four were suspected to have been caused by Verzenio, including one death.

Verzenio has been approved in Japan since last September and has been given to around 2,000 people according to the country’s Health, Labor and Welfare Ministry.