Eli Lilly's Taltz (ixekizumab) Receives the US FDA's Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
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- The approval is based on P-III study assessing Taltz (20mg for <25kg/40mg for 25-50kg/80 mg for >50 kg @12wks.- with 40/80/160mg starting doses- respectively) vs PBO in 171 patients aged 6-18 yrs. with mod. to sev. PsO who are candidates for systemic therapy or phototherapy
- The P-III study results: patients achieving PASI 75 (89% vs 25%); patients achieving sPGA 0-1 (81% vs 11%); safety profile in pediatric patients is consistent with adult patients
- Taltz is a mAb targeting IL-17A cytokine- inhibiting its interaction with the IL-17 receptor and has received its first FDA’s approval in Mar’2016 for mod. to sev. PsO and for active PsA & AS in adults in Dec’2017 & Aug’2019 respectively
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