Lilly wins EU approval for psoriatic arthritis mAb
The European Commission (EC) granted marketing authorisation (MA) for Lilly’s biologic Taltz last week as a treatment for active psoriatic arthritis (PsA) in adult patients who are intolerant to disease-modifying anti-rheumatic drug therapies.
This is the second indication granted for the drug after its approval in Europe for the treatment of moderate-to-severe plaque psoriasis in 2016. Lilly could look to scaling up production of the monoclonal antibody (mAb), a spokesperson told this publication.
“The active pharmaceutical ingredient for ixekizumab is made at Lilly's biotech manufacturing site in Kinsale, Ireland and the medicine is finished and distributed via Lilly's global manufacturing network,” we were told.
“Taltz is already approved for adult patients with active PsA in Japan and the US, as well as for psoriasis in many countries. Lilly has global manufacturing capabilities for Taltz and future plans take account of anticipated new market approvals.”
The site near Cork is one of the Big Biopharma’s largest manufacturing sites outside of the US. Recent plans have been unveiled to build a three-story biomanufacturing facility, adding 130 jobs at the site.
Psoriatic arthritis mAbs
Taltz is the latest in a list of monoclonal antibodies targeting psoriatic arthritis. Best-sellers Humira (adalimumab), Remicade (infliximab), Enbrel (etanercept) and their biosimilars are all approved to treat the indication.
But according to the spokesperson, this approval “provides physicians with an alternative treatment option for disease areas where we know there is still unmet patient need.
“Based on the results from two Phase III clinical trials, Taltz can provide significant improvement in joint symptoms for PsA patients who have never been treated with a biologic disease-modifying antirheumatic drug, as well as patients who have inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors.”