Lilly aims for new indication for Taltz

Eli Lilly is hoping new data from its Taltz (ixekizumab) could give it another potentially lucrative indication and put pressure on Novartis’ rival IL-17a drug, Cosentyx.

Already approved in psoriatic arthritis and psoriasis, Taltz has just met all its primary and secondary endpoints in the COAST-V trial in ankylosing spondylitis.

The FDA approved Cosentyx in ankylosing spondylitis and psoriatic arthritis two years ago, and in psoriasis three years ago and the drug has already achieved blockbuster-level sales.

Lilly is playing catch-up with Taltz, which was FDA-approved in March 2016 in psoriasis and in psoriatic arthritis at the end of last year.

COAST-V compared Taltz with placebo and AbbVie’s Humira (adalimumab), in patients who had never received a biologic disease-modifying anti-rheumatic drug.

An inflammatory condition that affects the joints in the spine, patients with ankylosing spondylitis experience a build-up in calcium and new bone in between their vertebrae in response to the inflammation, which reduces its ability to move and flex. The vertebrae may eventually fuse together.

Novartis’ Cosentyx has already been approved in this use on the basis of a 16-week study which measured the proportion of patients who achieved at least a 20% improvement compared with placebo in signs and symptoms of the disease as measured by a standard clinical scale.

Lilly has countered this by setting the bar higher and investigating whether Taltz could produce a statistically significant difference in the proportion of patients whose symptoms improved by 40% after 16 weeks compared with placebo, as measured by the same Assessment of Spondyloarthritis International Society scale.

Without revealing further efficacy details, Lilly said that the incidence of treatment-emergent adverse events was similar with Taltz compared with placebo.

The most common adverse events observed were consistent with the phase 3 studies of Taltz moderate-to-severe plaque psoriasis and active psoriatic arthritis.

Lilly will publish details of COAST-V at scientific meetings and journals later this year, and plans to file for regulatory approval once it gathers further data from Taltz later this year.

Eli Lilly’s Lotus Mallbris

Dr Lotus Mallbris, vice president and immunology platform team leader, Lilly Bio-Medicines, said: “Many people with this chronic, debilitating disease are still searching for an effective treatment. These initial results suggest that Taltz, if approved for this indication, may have the potential to help people with this challenging disease.”

There is another IL-17 drug – brodalumab, which was previously developed by AstraZeneca, but sold off to various companies in different regions after an unexpected link with suicidal ideation in clinical trials. This caused Amgen to walk out on an R&D partnership and development faltered as a result.

Marketed under the brand name Siliq by Valeant in the US, brodalumab is only FDA-approved in psoriasis.

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