Sun Pharma's partner Almirall applies for psoriasis drug approval in Europe

Two firms had entered into a licensing agreement for investigational drug tildrakizumab in July 2016

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Last Updated : Mar 24 2017 | 4:41 PM IST

Sun Pharma has announced that its Spanish partner Almirall SL has applied for a regulatory approval for psoriasis drug 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.

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, for which Almirall will have the right to primary negotiation. In addition, Almirall will be able to lead European studies, and participate in larger global clinical studies for psoriasis.

Almirall’s filing with EMA 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 sites.

“The filing of tildrakizumab in Europe is a significant step forward for healthcare providers as many patients are still suffering from the disease. Tildrakizumab adds a novel biologic treatment option to our extensive and innovative portfolio, strengthening our position as a leading Dermatology player,” said Eduardo Sanchiz, CEO, Almirall.

Jesper Jensen, executive vice president - biologics & dermatology, Sun Pharma, added, “Not all people living with psoriasis achieve long-term systemic control with currently available treatments, there are those who continue to struggle every day with the chronic nature of psoriasis. The European filing of tilidrakizumab is the next step in our effort to bring a new treatment option to people suffering from psoriasis.”

Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.5 million people in the US and approximately 125 million people worldwide. It is a noncontagious disorder that speeds the growth cycle of skin cells and results in thick scaly areas of skin. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed. Despite existing treatment options, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease.

Tildrakizumab is an investigational humanised, 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. Phase III tildrakizumab data provides further evidence for the role of the IL-23 pathway in helping to control the inflammatory process of psoriasis.