Guselkumab shows durable benefits in Crohn’s disease in LTE of phase 2 study

The interleukin-23 blocker guselkumab (Tremfya) continues to show promise in treating Crohn’s disease (CD). First winning FDA approval for plaque psoriasis in 2017, guselkumab recently demonstrated robust efficacy and a consistent safety profile in the long-term extension of the GALAXI Phase 2 study for CD.

Some 54.1% of patients receiving guselkumab achieved clinical remission by the three-year mark, compared to 46.0% for those treated with Stelara (ustekinumab), the company’s interleukin-12 and -23 antagonist that won FDA approval for CD in 2016. Patient-reported outcomes were also promising in the GALAXI trial, with 51.4% of guselkumab-treated patients achieving PRO-2 remission, a patient-reported outcome measurement used in inflammatory bowel disease (IBD) studies, compared to 39.7% for ustekinumab. From an endoscopic perspective, 34.7% of patients on guselkumab showcased a positive response, compared with 19.4% on ustekinumab.

An overview of GALAXI LTE …
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Legacy Healthcare aims to upend alopecia areata treatment with a botanical drug

Cross sections of plant stem under microscope view [tonaquatic/Adobe Stock]

Imagine a world where botanical drugs could shape the future of medical treatment. Saad Harti, CEO of Swiss company Legacy Healthcare, doesn’t just imagine it; he’s on a mission to make it a reality. With an initial focus on alopecia areata in children and adolescents, Legacy Healthcare believes the plant extract Coacillium could be a blockbuster, given its promise as alopecia areata treatment.

As he put it, it’s all about the “unique assembly of the right plants.” Coacillium contains four: Allium cepa L. (onion), Citrus limon (L.) (lemon), Theobroma cacao (cocoa) and Paullinia cupana Kunth (guarana). The composition, which includes a variety of flavonoids, polyphenols and methylxanthines, has been linked with reversing immuno-inflammatory reactions in hair follicles and adjacent dermal tissues.

Hopes an…
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European and Canadian authorities move to limit risk from JAK inhibitors

[Baricitinib image courtesy of PubChem]

The European Medicines Agency (EMA) is backing a series of measures to reduce the risk of serious side effects associated with Janus kinase (JAK) inhibitors, limiting their use in high-risk individuals.

Similarly, Health Canada is recommending updated labeling for the drug class to disclose the risk of serious cardiovascular events and cancer. The agency is working with Novartis (NYSE:NVS) to update Jakavi’s (ruxolitinib) labeling. Health Canada has already worked with manufacturers to update the labeling for the JAK drugs Cibinqo (abrocitinib), Inrebic (fedratinib), Olumiant (baricitinib,), Rinvoq (upadacitinib) and Xeljanz/Xeljanz XR (tofacitinib).

In 2021, FDA announced that it would require a warning for JAK inhibitors, indicating that they may lead to an elevated risk of cardiovascular events, cancer, blood clots and death.

Health Canada recommende…

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