Janssen has announced the launch of Tremfya in the UK for adults with moderate to severe plaque psoriasis, following a green light from European regulators.
Tremfya (guselkumab) is the first biologic approved to treat psoriasis that selectively blocks interleukin (IL)-23, a cytokine that plays a key role in initiating a specific immune inflammatory response in patients with the condition.
Psoriasis affects up to three percent of the UK population, an estimated 1.8 million people. It can cause great physical and psychological burden, with around one third of people with the condition experiencing depression and anxiety.
Tremfya’s marketing approval was based in part on findings from the VOYAGE 1 and 2 trials, which compared the drug with placebo and frequently-used treatment Humira (adalimumab). Data showed high levels of skin clearance after 16 weeks, with at least a 90 percent reduction in Psoriasis Area and Severity Index score (PASI 90) in 73.3 percent and 70.0 percent of patients given Tremfya, compared with 49.7 percent and 46.8 percent in those receiving Humira, respectively.
On the safety side, Janssen said there were no clear signals of increased risk of malignancy, major cardiovascular events or serious infections, including tuberculosis and re-activation of latent tuberculosis. Adverse events reported in at least 5 percent of patients treated with the drug included: nasopharyngitis, upper respiratory tract infection; injection site erythema; headache; arthralgia; pruritus; and back pain.
“We are delighted that guselkumab is now available for patients in the UK,” said Dr Frank Wiegand, medical director, Janssen UK. “The availability of guselkumab in the UK provides an innovative new option to help address the continued needs of people living with plaque psoriasis.”
A spokeperson for Janssen told PharmaTimes that the health technology assessment of Tremfya for the treatment of moderate to severe plaque psoriasis in adults by NICE is in progress.
“Based on current NICE timelines, we anticipate a decision from NICE by June 2018.”
The firm also plans to submit a HTA dossier to the Scottish Medicine Consortium in December 2017.
Tremfya was approved in the US for psoriasis in July.