New Psoriasis Biologic Ilumya Receives FDA Approval

How will it impact the competition?

Sun Pharma’s $80 million psoriasis licensing deal with Merck & Co. just paid off with an FDA approval, according to a FiercePharma report. But now, another challenge begins: The new med will go up against established psoriasis player Johnson & Johnson.

The FDA has officially green-lighted the Indian drug-maker’s tildrakizumab-asmn (Ilumya), an interleukin (IL)-23 inhibitor, to treat the skin plaque disease, Sun said. It’s “sort of a flagship product” for the company, which has only recently pivoted its focus to specialty pharma after many years on the generics scene, Chief Medical Officer Simon Lowry said in an interview with FiercePharma.

While pharma-watchers once believed tildrakizumab just might make it to market before head-to-head rival guselkumab (Tremfya, Johnson & Johnson), the New Jersey pharmaceutical giant ultimately usurped that lead and snagged its FDA go-ahead last July. And now it will be up to Sun to distinguish its newcomer with doctors.

The way Lowry sees it, that won’t be difficult. Tildrakizumab bears a less-frequent dosing schedule, requiring doses just every 12 weeks after two initial treatments, one to start and another at week 4. Guselkumab, on the other hand, is taken every eight weeks after the starter doses.

“We think that that will fit quite nicely with the natural flow of the dermatology office; bring the patient back every 12 weeks to see how they’re doing and administer the next dose,” Lowry told FiercePharma.

While less-frequent dosing may be more convenient for patients, guselkumab also has an at-home dosing option that could offer its own convenience edge. But that option also poses adherence uncertainties, Lowry pointed out.

“We’ve spoken to a lot of physicians who say they like the ability to bring the patient back in every 12 weeks and make sure they get their dose. When the patients are home, you aren’t sure whether they’re actually administering the drug or not,” he said.

Johnson & Johnson has an additional advantage, too, in its relationships with docs, the article said. The company also markets blockbuster ustekinumab (Stelara), an IL-12/IL-23 drug that’s been around for years. And while tildrakizumab isn’t Sun’s first branded dermatology product, comparatively speaking, it’s still early days for the company in the field.

Meanwhile, tildrakizumab is far from the only psoriasis newcomer that guselkumab will have to fight. The IL-17 field has seen a burst of recent activity from Novartis’ secukinumab (Cosentyx), Eli Lilly’s ixekizumab (Taltz), and Valeant’s brodalumab (Siliq). And secukinumab and ixekizumab have already expanded into areas such as psoriatic arthritis and ankylosing spondylitis, indications that Sun is developing tildrakizumab for as well.

Source: FiercePharma; March 22, 2018.