Tag Archive for: Crohn’s disease

BMS said its experimental drug to treat Crohn’s disease, a chronic inflammatory bowel condition, did not help patients achieve disease remission in a late-stage study.

The FDA on Friday approved Alvotech and Teva’s Simlandi (adalimumab-ryvk), a biosimilar to AbbVie’s blockbuster antibody therapy Humira (adalimumab), ending a long and difficult regulatory road for the partners.

Zymfentra is the first FDA-authorized subcutaneous formulation of infliximab, according to Celltrion’s announcement. The therapy is indicated for patients who had previously undergone intravenous infliximab treatment.

In a follow-up readout, data from the head-to-head SEQUENCE study showed that AbbVie’s Skyrizi induced better rates of steroid-free remission in Crohn’s disease than Johnson & Johnson’s Stelara.

The drug is among Lilly’s potential growth drivers for this decade alongside tirzepatide for obesity, lebrikizumab for atopic dermatitis or eczema and pirtobrutinib for cancer.

Continuing its clinical win streak, AbbVie’s Skyrizi showed signs of superiority against Johnson & Johnson’s Stelara in topline data from a head-to-head Phase III Crohn’s disease study.

As biosimilars and other next-generation treatments for Crohn’s disease enter the market, AbbVie will be knocked from its place of longtime dominance.

Following two BLA rejections for its Humira biosimilar, Alvotech is expanding its partnership with Teva Pharmaceuticals, which will enable the latter to have greater involvement with quality and control.

The sale of the drug could be announced in the coming days, the report said, citing people familiar with the matter. The talks could still fall apart and another suitor could swoop in, it added.

Merck finalized its acquisition of immune-focused Prometheus Biosciences for approximately $10.8 billion, scoring five clinical and pre-clinical candidates for inflammatory bowel and immune-mediated diseases on Friday.