MHRA Authorizes Cosentyx for Two Forms of Juvenile Arthritis
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Novartis’ Cosentyx (secukinumab), either alone or with methotrexate, for treatment of patients with two types of juvenile arthritis — enthesitis-related arthritis or juvenile psoriatic arthritis — whose disease has not responded to or who cannot tolerate conventional therapies.
The authorization was based on results from a phase 3 study in which participants given Cosentyx showed a significantly longer time to flare ups compared to those given a placebo. The risk of flares was reduced by 72 percent for two years.
An extension study evaluating of Cosentyx’s long-term efficacy, safety and tolerability up to four years in these patients is ongoing.
Novartis achieved sales of more than $4.7 billion for Cosentyx in 2021.