In December, Eli Lilly’s Taltz got a go-ahead to take on rival Cosentyx from Novartis in its second indication. But it’s not stopping there.
The Indianapolis drugmaker is eager to take the rivalry to a third arena—ankylosing spondylitis (AS)—and it’s rolled out new data that’ll help boost its chances.
In a phase 3 trial studying patients new to biologics, Taltz nailed its primary endpoint, significantly improving signs and symptoms of AS by the 16-week mark. Investigators measured success by tallying the proportion of patients to hit a prespecified score from the Assessment of Spondyloarthritis International Society (ASAS).
And as Lilly noted, it raised the bar higher than its rivals have: The trial was the first registration study to use the “40” benchmark from ASAS; the standard endpoint is ASAS20.
The company is still waiting for additional data before taking its case to regulators, but assuming it gets the necessary numbers, it plans to submit its approval applications later this year. And if it can nab the approval it’s seeking, it’ll go directly into battle with Cosentyx—again.
The Lilly med, which picked up its first approval in March of 2016, is already playing from behind the Novartis giant in both psoriasis and psoriatic arthritis (PsA). The Swiss pharma’s contender landed its psoriasis green light in early 2015, and it scored its PsA and AS approvals almost exactly a year later.
But that’s not to say the Lilly med isn’t near the front of pack overall. Valeant’s Siliq and Johnson & Johnson’s Tremfya both trailed Taltz with psoriasis approvals of their own, coming last February and last July, respectively.
Plus, Lilly’s excited about its prospects in PsA, which for now remains a less crowded field. As Christi Shaw, president of Lilly Bio-Medicines, pointed out on last month’s fourth-quarter earnings call, less than 40% of Cosentyx scripts come from the dermatology office, “so we believe this is a really large opportunity,” she said.
Lilly expects Taltz uptake in PsA will “be very similar” to Cosentyx’s, just as it was in psoriasis. “That market, we think, will be very large and we think we’re competitive,” she added.