Taltz is EU approved to treat psoriatic arthritis.-Eli Lilly.
Eli Lilly has revealed that its IgG4 monoclonal antibody Taltz (ixekizumab) has been awarded marketing approval from the European Commission for the treatment of active psoriatic arthritis (PsA) in patients for which disease-modifying anti-rheumatic drug (DMARD) therapies are not an option or have proved ineffective, when used alone or in combination with methotrexate.
The approval was based on data from two Phase III studies comprising 780 adult patients which analysed the proportion of biologic-na�ve and tumour necrosis factor inhibitor (TNFi)-experienced patients that achieved a 20% reduction in disease activity according to the American College of Rheumatology scale at 24 weeks, as well the number who achieved a 75% reduction in the Psoriasis Severity Index (PASI). The trials found that Taltz �achieved significant improvement in joint symptoms and skin symptoms� when compared to placebo.
. Comment: The psoriatic arthritis market is dominated by the anti TNF antagonists- Humira, Enbrel, Remicade, Simponi . In 2016 Humira, Enbrel, Remicade made sales of $832 million, $666 million and $171 million respectively. These drugs have biosimilar derivatives in development but only two biosimilars- Infliximab from Pfizer and Renflexis from Merck Inc, (in US) have been launched as the others are delayed by patent infringement litigation. New drugs for PsA include Xeljanz (tofactinib), twice a day oral drug approved in 2017, a JAK inhibitor from Pfizer, Taltz ( ixekizumab) monthly injection approved in the US in 2017, an Il- 17a antagonist from Eli Lilly, Simponi Aria (golilumab) with its modest efficacy but marketed at prices 30% lower than the anti TNF drugs and with a good side effect profile and Cosentyx (secukinumab), an Il-17A drug from Novartis. Stelara (ustekinumab), an IL-12/13 inhibitor has been the treatment of choice for patients who cannot accept TNF antagonist drugs but Stelara is being replaced by Cosentyx as the "preferred option" in second line treatment.
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