Baricitinib

Collectively, Johnson & Johnson has estimated that ulcerative colitis and Crohn’s disease affect nearly 3 million people living in the U.S. With a fresh endorsement from the FDA, Johnson & Johnson has rounded out Tremfya’s presence in inflammatory bowel disease (IBD) and, in doing so, achieved a first for the IL-23 inhibitor drug class.Friday, the FDA approved a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis (UC).The green light builds on Tremfya’s initial intravenous nod in UC secured last September, making the medicine the first IL-23 inhibitor to offer both under-the-skin injection and IV dosing options from the beginning of treatment through maintenance therapy for IBD patients, J&J said in a press release.Back in March, the drug—which also goes by the generic moniker guselkumab—won IV and subcutaneous approvals to treat adults with Crohn’s disease, the second manifestation of IBD alongside UC.Collectively, J&J has estimated that UC and Crohn’s affect nearly 3 million people in the U.S. While multiple other IL-23 therapies—such as AbbVie’s Skyrizi, Eli Lilly’s Omvoh and J&J’s own Tremfya predecessor Stelara—are also approved to tackle UC, the initial doses of those biologics must be infused, which can complicate the process for patients seeking treatment."Historically, IL-23 inhibitors have required IV infusions at the start of therapy, which can create barriers to starting treatment or be burdensome for some patients and clinicians," David Rubin, M.D., a director at University of Chicago Medicine who served as an investigator on J&J’s subcutaneous Tremfya study, said in a statement.The newly approved self-administration format has demonstrated efficacy and safety on par with Tremfya’s previously approved IV induction dose, Rubin added. The FDA based its approval on data from J&J’s late-stage Astro trial, which used a treat-through design to assess subcutaneous Tremfya in adult patients who hadn’t benefited from or had an intolerance to conventional and advanced UC colitis therapies.Injectable Tremfya's performance enabled the study to hit a range of primary and secondary endpoints, J&J noted in its approval announcement.Notably, Tremfya triggered an early symptomatic response in UC that diverged from placebo as early as two weeks into the trial, with those results sustained through the 24-week mark, J&J said.Meanwhile, 26% of patients on the 400-mg dose of J&J’s injectable drug achieved clinical remission at Week 12 of the study, versus just 7% of patients on placebo. Over that same span, 36% of subcutaneous Tremfya patients demonstrated endoscopic improvement, compared to 12% of participants in the trial’s control arm.Those data largely track with results seen in J&J’s study of intravenous Tremfya induction therapy in UC, even when accounting for subgroups of patients with severe or refractory disease, J&J said. Both dosing formats started to confer benefits to patients in a similar amount of time, the company added.Emboldened by the IBD data generated on Tremfya, J&J on Friday also noted that it is kicking off a head-to-head trial that will pit its drug against AbbVie’s Skyrizi in Crohn’s.For J&J, the study could present a redemption opportunity after AbbVie’s drug topped its Tremfya predecessor Stelara in a Crohn’s head-to-head in 2023.Skyrizi—which is one of two immunology drugs alongside Rinvoq that AbbVie has positioned to succeed Humira—secured a U.S. green light in UC last June. Prior to that, the IL-23 med nabbed a Crohn’s nod in 2022. Rinvoq is also approved in both indications but is part of the JAK inhibitor class rather than being an IL-23 drug. J&J has adopted a similar approach to AbbVie’s Skyrizi-Rinvoq strategy with Tremfya. J&J’s drug has been elevated to assume the immunology mantle from Stelara, which—like AbbVie’s Humira—is now facing biosimilar competition across multiple global markets.Earlier this year, J&J reported that Tremfya grew sales by 31% in the second quarter to $1.2 billion. The drug has already made a “great start” on its launches in both UC and Crohn’s, Jennifer Taubert, J&J’s executive vice president of innovative medicine, said on a July earnings call. 

Bengaluru: The U.S. Food and Drug Administration has approved Incyte's eczema cream for children aged between 2 and 11 years, the company said on Thursday. Wilmington, Delaware-based Incyte is banking on the eczema treatment, called Opzelura, as a key growth driver as it navigates the anticipated loss of exclusivity of its blockbuster blood disorder drug, Jakafi. The FDA approval was based on results from a late-stage trial, which demonstrated the treatment achieved higher efficacy when compared with a non-medicated cream. Eczema, or atopic dermatitis , is a skin condition marked by dry, itchy and inflamed patches. It affects an estimated 2-3 million patients aged two to 11 and more than 21 million people 12 years of age and older in the United States, Incyte said. Opzelura was approved for individuals aged 12 years and older with the disease in 2021, becoming the first topical JAK inhibitor, which blocks inflammation-causing enzymes Janus kinases, to be greenlit in the U.S. It is now the first of its kind approved for pediatric patients. Opzelura is also used to treat nonsegmental vitiligo, the most common form of vitiligo which causes symmetrical white patches on the skin. Sales of Opzelura are expected to double in the next five years from an expected $650 million this year, driven by the FDA and European approvals for the disease in adults and children, CEO Bill Meury said at the Cantor Global Healthcare Conference earlier this month. "We are now able to offer younger children with atopic dermatitis and their families a much-needed, steroid-free topical treatment option," Meury said on Thursday. Other drugs in the U.S. for children with eczema include topical steroids, Organon's Vtama, Arcutis' Zoryve for those six and older, and Sanofi and Regeneron's blockbuster Dupixent. (Reporting by Unnamalai L and Puyaan Singh in Bengaluru; Editing by Krishna Chandra Eluri)