- Eli Lilly & Co.'s autoimmune drug Taltz has gained a new indication that could give it better footing to compete with Novartis AG's Cosentyx.
- Taltz, which inhibits a inflammatory protein known as interleukin-17A (IL-17A), is now green lit to treat adults with active psoriatic arthritis. The medicine first received Food and Drug Administration approval in March 2016 for adults with moderate-to-severe plaque psoriasis.
- The label expansion means Taltz shares two of the same indications as Cosentyx. Though both drugs work on the IL-17 pathway, Novartis' secured an FDA OK about a year earlier — and therefore has had more time to lock down market share.
The market for IL-inhibiting drugs has grown quite crowded in just the last two years. Along with Taltz (ixekizumab) and Cosentyx (secukinumab), U.S. regulators have given a thumbs up to Sanofi SA and Regeneron Pharmaceuticals Inc.'s Dupixent (dupilumab), Johnson & Johnson's Tremfya (guselkumab) and Valeant Pharmaceuticals Inc.'s Siliq (brodalumab).
With the exception of Dupixent, all are indicated to treat moderate-to-severe plaque psoriasis. Differentiation has therefore become imperative for the drugs' manufacturers. Tremfya, for instance, targets IL-23. While that mechanism puts it directly in competition with Johnson & Johnson's blockbuster Stelara (ustekinumab), it at least separates the treatment from IL-17A inhibitors like Taltz and Cosentyx, as well as Siliq, which binds to the IL-17 receptor itself.
Lilly has maintained, however, that it doesn't see an IL-17 versus IL-17 battle for prescribing market share. Instead, the company has noticed patients who don't see their skin clear up after taking anti-tumor necrosis factor (TNF) agents are driving uptake as they switch over to treatments like Taltz.
Nevertheless, securing another indication — particularly one that puts it on a more equal playing field with Cosentyx — will likely help to grow Taltz revenues.
"We see our early adopters increasing their number of prescriptions. We see more physicians trying Taltz," said Christi Shaw, president of Lilly Bio-Medicines, during the company's third quarter earnings call. "With the psoriatic arthritis launch and our entry into the rheumatology office in December and January, given FDA approval, we should see another step level increase in Taltz."
The FDA based its latest Taltz approval on two Phase 3 studies, SPIRIT-P1 and SPIRIT-P2, which combined enrolled more than 670 patients who had active psoriatic arthritis and never were treated with a biologic disease-modifying antirheumatic drug.
Results from SPIRIT-P1 showed that after 24 weeks, 58% of patients taking Taltz achieved a 20% reduction in a composite measure of disease activity versus 30% for patients taking placebo. Similarly, 53% of patients taking Taltz in SPIRIT-P2 showed a 20% reduction in the composite measure versus 20% in the placebo arm.
"For patients with [psoriatic arthritis], treatment goals often include improvement in joint symptoms," Philip Mease, a rheumatologist at the Swedish Medical Center, said in a Dec. 1 statement from Lilly. "Based on the study results, Taltz can provide significant improvement in joint symptoms for patients who had never been treated with a biologic disease-modifying antirheumatic drug as well as patients who had inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors."