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Lilly claims another EU okay for Taltz

The IL-17 inhibitor can be used alone or in combination with methotrexate for PsA patients

Eli Lilly

Eli Lilly’s new immunotherapy Taltz has picked up a second indication in Europe, with the EMA approving the IL-17 inhibitor as a second-line treatment for active psoriatic arthritis (PsA) in adults.

Taltz (ixekizumab) was first approved as a treatment for psoriasis in 2016, and the new indication - which was approved in the US in December - is a boost as it plays catch-up in the market with Novartis’ first-to-market IL-17 inhibitor Cosentyx (secukinumab) which was approved for psoriasis several months earlier and has since had its uses extended to include PsA and ankylosing spondylitis.

The new approval means that Taltz can be used either alone or in combination with methotrexate for PsA patients who have responded inadequately to or who can’t tolerate one or more disease-modifying anti-rheumatic drug (DMARD) therapies.

Approval is based on two phase III trials - SPIRIT-P1 and SPIRIT-P2 - which showed that patients treated with the antibody achieved significant improvement in joint symptoms and skin symptoms compared with placebo.

SPIRIT-P1 evaluated the safety and efficacy of Taltz compared to placebo in patients with active PsA who had never been treated with a biologic DMARD drug, and 58% patients treated with the drug achieved a 20% reduction in a composite measure of disease activity (ACR20) versus 30% for placebo.

Similarly, in SPIRIT-P2, which pitted Taltz against placebo in patients previously treated with TNF inhibitors - one of the main classes of biologics used in PsA - the ACR20 responses were 53% and 20%, respectively.

“PsA affects up to 30% of people who are already living with psoriasis,” said Arash Tahbaz, senior medical director for Lilly’s UK and Northern Europe operations. “Symptoms often begin around a decade after the onset of psoriasis, and can severely impact people’s lives and ability to work.”

Novartis reported its fourth-quarter results for 2017 today, revealing that Cosentyx made just over $2bn in sales last year, a rise of 82% over 2016. Lilly hasn’t revealed its full-year results yet, but Taltz made $387m in the first nine months of 2017, so still has a long way to go to catch the leader.

A third IL-17 drug - Valeant’s Siliq (brodalumab) - was launched in the third quarter in the US at a discount to Cosentyx and Taltz but the company has yet to reveal preliminary sales performance. Siliq, originally developed by AstraZeneca (AZ), was approved by the FDA with a black box warning that it has been linked to suicidal thoughts and is only available through a restricted access programme.

Article by
Phil Taylor

24th January 2018

From: Regulatory

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