EMA approves Cimzia for use in treating plaque psoriasis
pharmafile | July 2, 2018 | News story | Sales and Marketing | Cimzia, EMA, UCB, indication, pharmaceutical
The Brussels-based pharmaceutical company UCB has announced that the European Medicines Agency (EMA) has approved a label extension for Cimzia (certolizumab pegol), to include a new indication in adult patients with moderate-to-severe plaque psoriasis.
The approval of the monoclonal antibody signals the multinational company’s entry into immune-dermatology. With an estimated 3% of the population or approximately 125 million people suffering from psoriasis across the globe, the disease area is one in which significant unmet need exists.
As expanded upon by Professor Richard Warren, Consultant Dermatologist at Salford Royal NHS Foundation Trust: “Despite available treatments, patients with moderate-to-severe plaque psoriasis can still experience poor control of symptoms, which can significantly impact their quality of life. Today’s approval provides patients and their healthcare professionals with a biologic option with 10 years of clinical experience in multiple inflammatory disease indications that may offer durable disease control for psoriasis patients in Europe.”
Furthermore the approval of Cimzia is significant as the first Fc-free, PEGylated anti-TNF treatment option for use in moderate-to-severe plaque psoriasis. Thus the recent approval makes the drug the first anti-TNF suitable for potential use in women during both pregnancy and lactation in its approved indications.
As stated by Jan Keegan, Head of Immunology UK and Ireland at UCB Pharma: “We are delighted to offer patients and healthcare professionals a new treatment option providing sustained efficacy and two different doses to maximise disease control and achieve clear skin. This EMA approval reinforces our commitment to providing valuable treatment solutions to patients for whom we can make a meaningful difference.”
Having been previously approved in combination with methotrexate for the treatment of moderate to severe active rheumatoid arthritis in the European Union, the drug’s effectiveness in treating plaque psoriasis was demonstrated in Phase 3 clinical trials in which it was tested on patients with moderate to severe plaque psoriasis. During the controlled clinical trials the proportion of patients who experienced adverse effects was just 3.5% in comparison with a rate of 3.7% for patients given a placebo.
Louis Goss
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