Lilly launches the world's second anti-IL-17A monoclonal antibody Taltz in the US

The new generation of anti-inflammatory drug Taltz (ixekizumab) developed by American pharmaceutical giant Eli Lilly was approved by the US FDA in March for adult patients with moderate to severe plaque psoriasis. At the end of last month, Taltz also received EU approval for the same indication. The drug is the world's second IL-17A monoclonal antibody approved after the Swiss pharmaceutical giant Novartis's heavy anti-inflammatory drug Cosentyx (secukinumab).

In terms of listing, Lilly is also unequivocal. The company recently announced the launch of Taltz in the US market. The listing of Taltz also marks the disintegration of the Novartis monopoly in the IL-17A monoclonal antibody market and poses a serious threat to Cosentyx. Both of these drugs are monoclonal antibodies that target the pro-inflammatory cytokine IL-17A, which is thought to play a key role in the inflammatory response of various autoimmune diseases.

In the United States, Taltz's specific indication is the treatment of adult patients with moderate to severe plaque psoriasis for systemic therapy (systemic therapy) or phototherapy. It should be noted that Taltz cannot be used in patients with hypersensitivity reactions (such as allergies) to the active pharmaceutical ingredient ixekizumab or any excipients .

Taltz's approval is based on the largest phase III clinical trial to date in the moderate to severe plaque psoriasis population. The project included three double-blind, multicenter phase III studies (UNCOVER-1, -2, -3) involving more than 3,800 adults with moderate to severe plaque psoriasis in 21 countries, and the results confirmed ixekizumab Efficacy and safety. These three studies evaluated the efficacy and safety of ixekizumab (initial dose of 160 mg, followed by dose of 80 mg every 2 weeks) compared with placebo for 12 weeks, in which the UNCOVER-2 study and the UNCOVER-3 study were also included. An additional control group was received in which patients received etanercept (50 mg, twice a week) for 12 weeks. The safety and efficacy of the three studies of the project will be further evaluated up to 60 weeks.

The results of the study showed that all three key studies met all major endpoints and key secondary endpoints of the study. ixekizumab was superior to Amgen's heavy anti-inflammatory drug Enbrel in all lesion regression indicators (Enli, generic name) : etanercept, etanercept) and placebo, the data were statistically significant. These data are important for patients with moderate to severe plaque psoriasis, and the approval of Taltz will help more patients with psoriasis to achieve overall relief.

About Taltz (ixekizumab ):

Ixekizumab is a monoclonal antibody that has a high affinity and specificity for the proinflammatory cytokine interleukin-17A (IL-17A) and inhibits the binding of IL-17A to the IL-17 receptor. For patients with psoriasis, IL-17A plays an important role in driving hyperproliferation and activation of keratinocytes (skin cells). Ixekizumab does not bind to the cytokines IL-17B, IL-17C, IL-17D, IL-17E or IL-17F. Ixekizumab is administered by subcutaneous injection. At present, Lilly is also advancing clinical research on ixekizumab for the treatment of psoriatic arthritis and other inflammatory diseases .