FDA approves Lilly’s psoriasis drug, Teva’s asthma treatment
Eli Lilly’s Taltz (ixekizumab) has been approved in the US for moderate-to-severe plaque psoriasis, along with Teva’s asthma drug Cinqair (reslizumab).
The US Food and Drug Administration today approved use of the injection in adults who are candidates for systemic therapy or phototherapy.
Taltz, a rival to Novartis’ Cosentyx (secukinumab), could generate sales of $558 million by 2019, according to some analysts.
It is designed to target IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.
Approval was based on phase 3 data from three studies – UNCOVER-1, UNCOVER-2 and UNCOVER-3. Comparator data from UNCOVER-2 and UNCOVER-3 showed Taltz was statistically superior to Amgen/Pfizer’s Enbrel (etanercept), at all skin clearance levels.
These were measured by co-primary endpoints of 75% improvement in composite Psoriasis Area Severity Index score and a doctor’s assessment of skin lesions.
Patients treated with Taltz had higher rates of infections than patients treated with placebo. There was also a higher rate of serious adverse events on Taltz (2%) during a 12-week induction period, compared with Enbrel (0.7%).
Rate of discontinuation due to adverse events was also 2% for Taltz and 0.7% for Enbrel.
Meanwhile the FDA also approved Teva’s Cinqair, for add-on maintenance treatment in adults with severe asthma and an eosinophilic phenotype. Cinqair is an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) and has been approved in patients aged 18 years and older.
Both drugs will be launched in the second quarter.
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