Taltz Approved for Psoriasis
March 22, 2016 – The U.S. Food and Drug Administration granted approval for Taltz (ixekizumab); a biologic drug that binds to interleukin (IL) -17A and inhibits interaction with the IL-17 receptor, thereby decreasing inflammation. It is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Psoriasis is a chronic immune system disease that affects approximately 7.5 million Americans. It is characterized by red, scaly, patches on the skin. 20% of psoriasis cases are considered moderate-to-sever plaque psoriasis. Taltz is available in 80mg/mL solution in a single-dose prefilled auto injector and in an 80mg/mL solution in a single-dose prefilled syringe. The recommended dose for use is 160mg at Week 0, 80mg at Weeks 2, 4, 6, 8, 10, and following week 10, 80 mg every 4 weeks. Although the launch date is anticipated for the second quarter of 2016, the pricing information for Taltz is not yet available.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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.