Johnson & Johnson has a new indication for anti-inflammatory med Stelara--and not a moment too soon.
Monday, the FDA green-lighted the med as a treatment for Crohn’s disease, basing the approval on clinical trial data that showed Stelara could provide relief at the 6-week mark to a significant percentage of patients.
It’s a win for J&J, which is looking to Stelara to keep bringing in blockbuster numbers despite a raft of new psoriasis competitors. After hauling in $2.47 billion in 2015 sales, the product this year went up against Eli Lilly’s Taltz, a next-gen rival that joined the fray behind Novartis’ new-age contender Cosentyx.
That trend won’t be going away anytime soon. Valeant is still waiting on an FDA decision for advisory committee-backed brodalumab, for one, while Amgen last week netted a go-ahead for its biosimilar of AbbVie anti-TNF giant Humira--though when that med may actually launch is still up in the air because of patent litigation.
Things are heating up in the psoriatic arthritis field, too, where Stelara boasts its other indication. Cosentyx won a label expansion for that ailment in January, and Pfizer is working on snagging its own for its own rival, Xeljanz.
That’s not to say Stelara won’t face its fair share of competitors in the Crohn’s arena. Anti-TNF heavyweights including Humira and J&J’s own Remicade currently play in the space, and biosimilars that do the same are on the way.
J&J’s Janssen unit, though, was quick to point out that Stelara is the first biologic of its kind in Crohn's--it targets IL-12 and IL-23 cytokines--and “not all therapies work for every patient,” study investigator William Sandborn said in a statement.
Janssen also plans to work closely with payers, providers and PBMs to secure top access for its blockbuster. The company will ensure that “the cost for payers is competitive with currently available biologic therapies” for Crohn’s, it said.
- read the release
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