Guselkumab

Dive Brief:Takedas experimental autoimmune drug zasocitinib bested Bristol Myers Squibbs marketed medicine Sotyktu in a head-to-head study in psoriasis, the company said Thursday. Takeda didnt provide detailed data, but said that zasocitinib demonstrated statistical superiority against Sotyktu on all main and secondary study goals. After 16 weeks, zasocitinib helped completely eliminate the skin lesions in over a third of recipients, more than doubling what was seen with Sotyktu. Its the second time Takedas drug has beaten an approved therapy, following positive results in a trial testing it against Amgens Otezla.Zasocitinib is a newer kind of TYK2 inhibitor, a class of oral autoimmune medicines that have attracted significant industry investment in recent years. Its become a star prospect for Takeda, which acquired the therapy from Nimbus Therapeutics for $4 billion upfront and started a series of high-stakes trials to establish its commercial potential. But zasocitinib is close to entering a crowded market that includes many other medications, among them a new pill from Johnson & Johnson.Dive Insight:Sotyktu was the first TYK2 inhibitor to gain Food and Drug Administration approval.But it hasnt yet become the kind of seller Bristol Myers once hoped. The drug recorded $291 million in revenue in 2025 and, with an expected clearance coming in psoriatic arthritis, Bristol Myers recently revealed plans to no longer promote Sotyktu in dermatology in many markets.Polling by some analysts has suggested that many dermatologists prefer injectable biologics due to Sotyktus lower efficacy. Takeda, then, may have to convince doctors that zasocitinib is clearly better if it hopes to draw patients away from effective shots like AbbVies Skyrizi and J&Js Tremfya.The company, for its part, has been optimistic about zasocitinibs chances. On a May earnings call with analysts, CEO-elect Julie Kim claimed the drug is poised to be a leading oral treatment option with the potential to significantly expand the growing market for psoriasis pills.When you look at the market, oral treatments are already the fastest-growing segment, with the number of patients on advanced oral therapy expected to triple over the next decade, Kim told analysts.The study results disclosed Thursday could help Takedas case. In the head-to-head trial,zasocitinib helped 35% of the people who took it achieve a measure called PASI 100, a benchmark of complete skin clearance with no visible lesions. That figure was 2.5-times better than Sotyktu, a statistically significant difference that met the studys main goal. Takeda didnt state the exact number associated with Sotyktu, but in Bristol Myersclinical trials, up to 14% of trial enrollees hit the PASI 100 mark.Zasocitinib was also statistically better than Sotyktu on all secondary endpoints, which included partial skin clearance measures such as PASI 90 and PASI 75. The PASI 100 rate would fall short of whats been seen in testing of Skyriziand Tremfya, although zasocitinib hasnt been evaluated directly against those drugs.As expectations for oral therapies continue to rise, these findings support the potential of zasocitinib to help transform what patients and physicians can expect from an oral option in plaque psoriasis, said Linda Stein Gold, the director of dermatology clinical research at Henry Ford Health and a lead trial investigator, in a statement.An equally important trial readout is expected for zasocitinib in inflammatory bowel disease later this year. Two TYK2 drugs, including Sotyktu, have failed studiesin people with ulcerative colitis or Crohns disease. '

FDA OKs broader psoriatic arthritis label for J&J's Tremfya WHO backs Regeneron antibody for Bundibugyo Ebola trialsMannKind's needle-free insulin get US nod for young peopleFDA OKs broader psoriatic arthritis label for J&J's TremfyaThe FDA greenlit an expanded label for Johnson & Johnson's Tremfya (guselkumab) to now include inhibition of structural joint damage progression in adults with active psoriatic arthritis (PsA); the mAb had secured the agency's approval to treat PsA back in 2020.The label expansion was supported by data from the Phase IIIb APEX trial, wherein Tremfya delivered substantially higher rates of clinical improvement and notable inhibition of structural damage progression versus placebo in biologic-naïve patients. Emphasising that "up to half of all patients living with active [PsA] can develop early irreversible joint damage," Brandee Pappalardo, VP of medical affairs at J&J's dermatology & rheumatology division, said the latest update makes Tremfya the "only IL-23 inhibitor with structural inhibition in its label."-Pavan KamatWHO backs Regeneron antibody for Bundibugyo Ebola trials Regeneron said the World Health Organization (WHO) recommended maftivimab — the primary neutralising antibody component of the Ebola treatment Inmazeb (maftivimab/atoltivimab/odesivimab-ebgn) — for prioritisation in clinical trials targeting Bundibugyo ebolavirus, following the agency's declaration of a public health emergency of international concern earlier this month over the ongoing outbreak in the Democratic Republic of the Congo (DRC) and Uganda.The company said the WHO recommendation signals a critical step in expanding Inmazeb's therapeutic reach beyond its current FDA-approved indication for Zaire ebolavirus. Although maftivimab has demonstrated broad neutralising activity against Bundibugyo in vitro, it is yet to be evaluated as a monotherapy in vivo against the strain.Meanwhile, Regeneron is prepping existing maftivimab supply for potential trials, with Inmazeb already positioned on the ground in the DRC. "Independently run and locally executed clinical trials are critical to developing effective new medicines in such situations," said CEO Leonard Schleifer.-Pavan KamatMannKind's needle-free insulin get US nod for young peopleMannKind said the FDA approved its Afrezza inhalation powder for children and adolescents aged six and older with type 1 or type 2 diabetes, making it the first and only inhaled mealtime insulin cleared for paediatric use in the US.The ultra rapid-acting insulin, which delivers insulin into the bloodstream through the lungs using MannKind's proprietary Technosphere platform, was first approved for adults in 2014. Afrezza generated sales of $74.6 million in 2025.The latest clearance was backed by data from the Phase III INHALE-1 trial in paediatric patients."For more than a century, insulin therapy for children living with diabetes has largely meant multiple daily injections," said CEO Michael Castagna. "Afrezza allows dosing at the moment of eating, without the need for pre-meal planning, making it a practical option for unplanned meals and snacks on the go."-Anna Bratulic