Regulatory filing of tildrakizumab in Europe

Published: 27-Mar-2017

Potential of tildrakizumab for patients with moderate-to-severe plaque psoriasis, without burden of frequent injections

Dermatology and aesthetics-focused company Almirall and Sun Pharma, a Indian specialty generic pharma company, have received validation of the Regulatory Filing of tildrakizumab with the European Medicines Agency (EMA).

Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis.

"Not all people living with psoriasis achieve long-term systemic control with currently available treatments,” said Jesper Jensen, Executive Vice President of Biologics and Dermatology at Sun Pharma.

“The European filing of tilidrakizumab is the next step in our effort to bring a new treatment option.”

In July 2016, Almirall entered into a licensing agreement with Sun Pharma for the development and commercialisation of tildrakizumab for psoriasis in Europe.

Under the terms of the signed agreement, Sun Pharma will continue to lead other indications. Almirall will be able to lead European studies and participate in larger Global clinical studies for psoriasis.


Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23.

With this precise targeting, tildrakizumab has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system.

Psoriasis affects approximately 125 million people worldwide, with plaque psoriasis as the most common form. Despite existing treatment options, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease.

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