Lilly’s new psoriasis drug ixekizumab has cleared a crucial hurdle on the path to approval after hitting targets across three Phase III studies.
The drugmaker said its monoclonal antibody met both primary and secondary endpoints in the UNCOVER programme, and beat Pfizer’s Enbrel (etanercept) on all measures of skin clearance.
Most notably, for patients treated with ixekizumab either every four weeks or every two weeks, between 78% and 90% of patients achieved at least a 75% reduction in the Psoriasis Area and Severity Index score at 12 weeks.
Also, 31%-41% of these patients achieved PASI 100, or clear skin, at week 12, compared to just 5%-7% of patients taking Enbrel in the UNCOVER-2 and 3 studies.
Filing early next year
On the back of the data, Lilly says it is planning to submit its drug to regulatory authorities in the first half of next year. But it won’t be alone, given that there are quite a few contenders coming through the late-stage pipeline.
Phase III data from Novartis’ offering secukinumab published last month showed that the drug also had superior efficacy to Enbrel; over half of secukinumab patients experienced clear (PASI 100) or almost clear (PASI 90) skin by Week 12 compared to just 20.7% of Enbrel-treated patients.
Also coming nearing the finish line are Amgen and AstraZenec’s brodalumab, Celgene’s Otezla (apremalist) and Merck's MK-3222, not to mention Enbrel biosimilars being pursued by various companies, including Novartis.