Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Ilumetri®
Therapeutic area: Autoimmune diseases - Dermatological diseases - Inflammatory diseases
- monoclonal antibody. Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23. In clinical studies for the treatment of chronic plaque psoriasis, tildrakizumab demonstrates efficacy in blocking inflammation by blocking IL-23. Other potential indications, which may be evaluated in future, include psoriatic arthritis and Crohn’s disease.
- The drug has been initially developed by Merck&Co. In September 204, Merck & Co and Sun Pharmaceutical Industries have concluded a licensing agreement for tildrakizumab, (MK-3222).
- In July 2016, Sun Pharma had announced a strategic licensing agreement with Almirall on the development and commercialization of tildrakizumab for psoriasis in Europe.
Company: Merck&Co (USA - NJ) Sun Pharmaceutical Industries (India) Almirall (Spain)
- moderate-to-severe plaque psoriasis
- • On July 26, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,
recommending the granting of a marketing authorisation for Ilumetri®, intended for the treatment of moderate to severe plaque psoriasis. Ilumetri® will be available as a 100-mg solution for injection. The benefits with Ilumetri are its ability to reduce the immune response and inflammatory process, and thereby improve the signs and symptoms of patients with moderate to severe plaque psoriasis. The most common side effects are upper respiratory tract infections, gastroenteritis, nausea, diarrhea, headache, injection site pain and back pain.
- • On May 24, 2017, Sun Pharmaceutical Industries announced the FDA acceptance of the Biologics License Application (BLA) for tildrakizumab for the treatment of moderate-to-severe plaque psoriasis. The BLA filing for tildrakizumab was submitted by Merck&Co.
The BLA filing for tildrakizumab with the FDA is based on two pivotal Phase III trials (reSURFACE 1 and 2) which included over 1,800 patients across more than 200 clinical trial sites, including some patients who have been treated with tildrakizumab for up to three and a half years. Data from these trials were most recently presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in March and previously presented at the 25th European Academy of Dermatology and Venereology Congress.
- • On March 24, 2017, Almirall and Sun Pharmaceutical Industries announced the validation of the Regulatory Filing of tildrakizumab with the European Medicines Agency (EMA) by Almirall. The filing includes efficacy and safety data from the pivotal Phase III clinical trials (reSURFACE 1 and 2) that included over 1,800 patients across more than 200 clinical
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE: 2018-07-26
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: