- Eli Lilly on Monday won an expanded approval for its psoriasis and arthritis drug Taltz, securing a Food and Drug Administration OK that should help the Indianapolis pharma level the playing field with rival Novartis.
- Taltz, part of a class of drugs known as IL-17 inhibitors, is now cleared to treat ankylosing spondylitis, a type of arthritis that often manifests as chronic back pain. The new indication is Taltz's third, after its 2016 and 2017 approvals for plaque psoriasis and psoriatic arthritis, respectively.
- Taltz's label now matches that of Novartis' competing drug Cosentyx, which currently leads the IL-17 class by total prescription numbers. Both drugs are newer entrants in a competitive field that includes top-selling treatments like AbbVie's Humira and Amgen's Enbrel.
Compared to the better known rheumatoid arthritis, ankylosing spondylitis gets less attention. But it's a key part of both Lilly's and Novartis' plans to grow the market for their respective drugs.
"Only 15% of the patient population are using biologic medicines," said Rebecca Morison, a vice president of U.S. immunology at Lilly, in an interview with BioPharma Dive. Taltz (ixekizumab) and Cosentyx (secukinumab) are biologics, as are the older tumor necrosis factor (TNF) inhibitors.
"There's a big gap there in terms of patients seeking out or having access to more efficacious medicines. Having Taltz come to the market gives physicians more options," Morison added.
By comparison, roughly half of patients treated for rheumatoid arthritis in the U.S. receive biologic therapies, according to Novartis market research from 2017.
For many, biologic therapy means TNF inhibitors, which continue to enjoy widespread use even as newer therapies are approved.
Last week, the American College of Rheumatology updated its treatment guidelines, including a conditional recommendation to treat ankylosing spondylitis using TNF inhibitors rather than with Cosentyx, Taltz or Pfizer's drug Xeljanz (tofacitinib). The group recommended Cosentyx or Taltz over Xeljanz, however.
Lilly estimates roughly 1.6 million people in the U.S. have ankylosing spondylitis, which is also known as radiographic axial spondyloarthritis.
Two Phase 3 studies supported Taltz's approval in the indication: one testing the drug in patients who were naive to treatment with biologic arthritis drugs, and another in patients who didn't respond well or became intolerant of TNF inhibitors.
Results showed significantly more patients on Taltz achieved a measure of response known as ASAS40 four months after treatment, compared to those who received placebo.
Lilly's current price for Taltz is $5,368 per individual pen. For ankylosing spondylitis patients, the recommended dosing is two 80 mg injections at treatment initiation, followed by one 80 mg injection every four weeks.
Cosentyx is priced similarly, costing $5,178 a month for either the 150-mg or 300-mg dosage strengths.
Jacob Bell contributed reporting.