EU approves UCB’s Cimzia to treat psoriasis
Our expert's opinion
"A month ago, I showed you an article stating that the US authorities just approved the usage of Cimzia (a combination product developed and produced by UCB, a Belgian Pharmaceutical Company) for treatments against psoriasis (you can find that article here).
This week, it is the turn of the EU authorities; The European Medicines Agency (EMA) just gave the same green light! The labels of all the Cimzia products destined for the European market will have to be changed to be compliant for plaque psoriasis treatments, as the product already exist but could only be used to treat other diseases. If you have experience in labelling (at all levels) and/or in regulatory affairs, be sure to stay sharp as interesting projects might appear soon."
- Antoine Desprez, Associate Consultant
EU green light for Cimzia to treat psoriasis
The European Medicines Agency has approved a label extension for UCB’s Cimzia allowing its use to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
The approval makes Cimzia (certolizumab pegol), the first Fc-free, PEGylated anti-TNF treatment option for use in moderate-to-severe plaque psoriasis “and marks the entry of UCB into immuno-dermatology, where significant unmet need currently exists,” the firm noted.
The CIMPASI-1 and -2 and CIMPACT trials confirmed the efficacy and safety of the drug in this setting.
In all three trials, the drug showed “statistically significant improvements for all primary and co-primary endpoints compared to placebo at all tested doses”, and the clinical benefit was maintained through to week 48, according to the firm.
In the CIMPACT trial, the response rate for patients who achieved a PASI 75 after 12 weeks’ treatment was 66.7 percent for those receiving Cimzia 400mg every two weeks and 61.3 percent for those getting Cimzia 200mg every two weeks, compared to just 5.0 percent for patients in the placebo group.
At week 16, response rates for patients who achieved a PASI 75 were 74.7 percent and 68.2 percent, respectively, versus 3.8 percent for those taking a placebo.
“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.
“[The] 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,” said Professor Richard Warren, consultant dermatologist, Salford Royal NHS Foundation Trust.
Psoriasis affects nearly three percent of the population, or around 125 million people worldwide.
In Europe, Cimzia is already approved as a treatment for rheumatoid arthritis, active psoriatic arthritis and axial spondyloarthritis (axSpA).
Source: Pharma Times