Eli Lilly ($LLY) won FDA approval for ixekizumab, a blockbuster hopeful that will compete against a new wave of rival therapies for psoriasis. The drug will be sold as Taltz.
Analysts expect the IL-17A anti-inflammatory drug to carve out a market worth more than a billion dollars a year by 2020, making this one of Lilly's top drug prospects and a key part of its case that the pharma giant will continue to bounce back from a low point in 2014. Just weeks ago the European Medicines Agency signaled its approval for the therapy, paving the way to another big market later this year.
Lilly will follow in the footsteps of Cosentyx, the first IL-17A drug to hit the market after Novartis gained a pioneering approval. In January Novartis added two new approvals for their drug--for psoriatic arthritis and ankylosing spondylitis--as it pushes for up to $5 billion in potential peak sales. And there's good reason to believe that Lilly will follow up with a market-expanding approval later this year for psoriatic arthritis.
Novartis took the news in stride, though, Tweeting out a quote from pharma chief David Epstein: "FDA approval of 2nd IL-17A #psoriasis treatment from @LillyPad good news for patients."
Lilly often finds itself facing off against several heavyweight challengers when it does win an approval, and Taltz is no different on that score. Johnson & Johnson ($JNJ) execs are bullish about the blockbuster potential for their late-stage program for the IL-23 drug guselkumab. Merck ($MRK) is also in the race, with MK-3222. AstraZeneca ($AZN) had been a contender as well, but patients taking brodalumab complained of suicidal thinking, which persuaded Amgen ($AMGN) to drop its partnership. AstraZeneca then sold the drug to Valeant ($VRX), a bottom-feeding pharma company that is now struggling to survive an existential crisis.
Ixekizumab binds to the protein interleukin (IL)-17A, which triggers inflammation. And Lilly aimed straight for a top role in the market by including head-to-head late-stage studies against market leaders, including Enbrel.
A Lilly spokesperson told FierceBiotech that the company never reveals its new drug prices until the actual market launch. But they're tackling a big market. Psoriasis is a chronic, immune disease that afflicts some 7.5 million Americans, with roughly one in 5 suffering from moderate-to-severe plaque psoriasis.
"Many people living with plaque psoriasis are looking for another treatment option for this disease," said Alex Azar, president, Lilly USA, in a statement. "With this FDA approval, we are proud to provide patients and dermatologists with a new choice that may provide significant improvement of psoriasis plaques."
"Today's approval provides patients suffering from plaque psoriasis with another important treatment option to help relieve the skin irritation and discomfort from the condition," said Dr. Julie Beitz, director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research.
- here's the release