Taltz Receives Label Update
May 22, 2018 – The U.S. FDA has approved a label update for Taltz® (ixekizumab) injection 80 mg/mL, manufactured by Eli Lilly. The label will now include data regarding treatment of psoriasis in genital areas.
Originally approved in 2016 to treat adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, Taltz is now the first and only such treatment to include information on psoriasis in genital areas on its label.
Pete Salzmann, vice president of Lilly Immunology, stated in a press release that “up to 63 percent of psoriasis patients will be impacted by psoriasis involving the genital area over the course of their disease. However, there remains a serious unmet need for patients seeking treatment options.” The label update will allow Taltz to be used to meet the needs of these patients.
The label update is based on a clinical study in which patients experienced a significant improvement in symptoms when using Taltz versus a placebo. Seventy-three percent of patients were clear or had minimal symptoms after 12 weeks on Taltz, versus just 8% of patients who received the placebo.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.