LILLY RECEIVES MHRA MARKETING AUTHORISATION IN GREAT BRITAIN FOR MIRIKIZUMAB (OMVOH ®▼) FOR THE TREATMENT OF ELIGIBLE ADULTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS.1

• Mirikizumab is the first IL-23p19 targeted biologic to demonstrate efficacy for induction and maintenance therapy of moderately to severely active Ulcerative Colitis.
• Marketing authorisation was based on two randomised, double-blind, placebo-controlled phase 3 trials, LUCENT-1 and LUCENT-2. In both studies mirikizumab achieved primary and key secondary endpoints, including sustained clinical remission1
• Decreases in bowel urgency severity were observed as early as week 2 in patients treated with mirikizumab versus placebo in LUCENT-11

BASINGSTOKE, June 28, 2023 – Eli Lilly and Company announced today that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation (MA) for mirikizumab (OMVOH ®) for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.1

“Ulcerative colitis is a chronic, relapsing inflammatory disorder affecting the large intestine. It is characterised by symptoms of diarrhoea, bleeding and urgency, with multidimensional, and often negative effects on patients’ personal, psychological, professional and social well-being. Our understanding of the aetio-pathogenesis is improving, but our treatment options remain limited,” said Professor Jimmy Limdi, Consultant Gastroenterologist/Head of IBD Section at Northern Care Alliance NHS Foundation Trust and Professor of Gastroenterology at University of Manchester. “The recent authorisation of Mirikizumab, the first IL-23p19 inhibitor, is positive news for eligible people living with ulcerative colitis and gastroenterologists/specialists caring for them. It is a significant scientific advance welcomed by the medical community.”

Sarah Sleet, Chief Executive of Crohn’s & Colitis UK, welcomes the news: “Over 500,000 people in the UK are living with Crohn’s Disease and Ulcerative Colitis. They are lifelong conditions for which there is no known cure, and the symptoms are painful and debilitating. Existing medications may not work for some people, or indeed stop working for others. Expanding the treatment options for eligible people living with Colitis is a promising step forward and we welcome the MHRA’s decision to authorise mirikizumab.”

“This authorisation establishes mirikizumab as the first IL-23p19 antagonist to be authorised in Great Britain for the treatment of adults with moderate to severe Ulcerative Colitis and reflects our commitment to immunological diseases with high unmet need,” said Laura Steele, President & General Manager, Northern Europe, Eli Lilly and Company. “We understand the importance of having novel treatment options for eligible patients and Lilly would like to thank the patients and investigators around the world who have made this possible.”

The authorisation was based on results from the LUCENT program, which included two randomised, double-blind, placebo-controlled Phase 3 clinical trials, consisting of one 12-week induction study (LUCENT-1) and one 40-week maintenance study (LUCENT-2) for 52 weeks of continuous treatment.

In the LUCENT-1 induction study, 1,162 patients were included in the primary efficacy population. Patients were randomised 3:1 to receive mirikizumab (300 mg) intravenous (IV) or placebo IV every 4 weeks for 12 weeks. After 12 weeks of treatment with mirikizumab 24.2% (n=210/868) of patients achieved the primary endpoint of clinical remission compared to 13.3% (n=39/294) of placebo.1

544 patients who achieved a clinical response with mirikizumab in LUCENT-1 (63.5%, n=551/868) were re-randomised 2:1 to receive mirikizumab (200 mg) subcutaneous injection or placebo subcutaneous injection every 4 weeks for another 40 weeks in LUCENT-2. Of the LUCENT-1 patients who achieved clinical response at 12 weeks, 49.9% (n=182/365) achieved clinical remission (primary end point) and 43.3% (n=158/365) achieved histologic-endoscopic mucosal remission (secondary end point) at one year, compared to placebo (25.1%, n=45/179 and 21.8%, n=39/179 for clinical remission and histologic-endoscopic mucosal remission, respectively).1

Patients treated with mirikizumab achieved a greater reduction in rectal bleeding and stool frequency subscores as early as two weeks. The LUCENT studies also investigated endpoints such as bowel urgency remission and bowel urgency severity using the validated Urgency Numeric Rating Scale (NRS) of 0-10, with zero being no urgency and 10 being worst possible urgency. Decreases in bowel urgency severity were observed as early as two weeks in patients treated with mirikizumab. After treatment with mirikizumab, 42.9% (n=144/336) of patients achieved bowel urgency remission at one year, compared to 25% (n=43/172) of placebo.1

The Phase 3 LUCENT clinical program also evaluated the safety profile of mirikizumab. The most frequently reported adverse reactions are upper respiratory tract infections (7.9 %, most frequently nasopharyngitis), headache (3.3 %), rash (1.1 %) and injection site reactions (8.7 %, subcutaneous injection, LUCENT-2).1

Adverse reactions from clinical studies (Table 1) are listed by MedDRA system organ class. The frequency category for each reaction is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000).

Table 1 : Adverse Reactions

a Includes: acute sinusitis, nasopharyngitis, oropharyngeal discomfort, oropharyngeal pain, pharyngitis, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, and viral upper respiratory tract infection.

b Includes: rash, rash macular, rash maculo-papular, and rash papular and rash pruritic.

c Reported in the mirikizumab LUCENT-2 study where mirikizumab treatment is administered as subcutaneous injection.

d Reported in the mirikizumab LUCENT-1 study where mirikizumab treatment is administered as intravenous infusion.1

About Ulcerative Colitis

Ulcerative colitis (UC) is a chronic immune-mediated inflammatory condition of the large intestine. It is frequently associated with inflammation of the rectum but often extends proximally to involve additional areas of the colon. Patients with new-onset UC often present with characteristic symptoms of an inflamed rectum, namely, bleeding, urgency, and tenesmus. The management of UC must involve a prompt and accurate diagnosis, assessment of the patient’s risk of poor outcomes, and initiation of effective, safe, and tolerable medical therapies.2

About mirikizumab

Mirikizumab is an interleukin-23p19 antagonist indicated for the treatment of moderately to severely active ulcerative colitis in adults. Mirikizumab selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of UC. Treatment with mirikizumab starts with 300-mg IV infusions at weeks 0, 4 and 8. After completion of the induction dosing, the maintenance dose of mirikizumab is 200mg by subcutaneous injection every four weeks in two 100-mg pre-filled syringes or two 100mg pre-filled pens.1

▼  This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

To arrange an interview or for further information please contact:

Media contact: Louisa Stevenson/Lorna May Lilly UK Press Office Phone: +44 20 3162 0046

Email: ukpublicaffairs@lilly.com

Kate Perry/Tricia Persad-Bevil, JPA Health

Phone: +44 (0) 7792 215873 / +44 (0) 7792 524442

Email: kperry@jpa.com/ tpersad-bevil@jpa.com

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high- quality medicines that meet real needs, and today we remain true to that mission in all our work.

Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at: www.lilly.co.uk

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REFERENCES

1 Summary of Product Characteristics available from UKMedInfo@Lilly.com

2 REF Rubin DT, Ananthakrishnan AN, Siegel CA, Sauer BG, Long MD. ACG Clinical Guideline: Ulcerative Colitis in

adults. Am J Gastroenterol. 2019;114:384-413. ACG Clinical Guideline: Ulcerative Colitis in Adults - PubMed (nih.gov)