The agency’s decision will help Lilly enter a sector, where drugs from rivals such as Abbvie, Pfizer, and Johnson & Johnson are already jostling for a share of the multi-billion dollar market.
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.
Today Pfizer announced the FDA’s approval of VELSIPITY, an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC), a condition that produces debilitating symptoms such as chronic diarrhea with blood and mucus, abdominal pain, and urgency and affects approximately 1.25 million people in the United States.
Despite meeting the primary endpoint and eliciting endoscopic improvements in ulcerative colitis, Morphic Therapeutic’s investigational pill underwhelmed investors with its stock plummeting.
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.
British drugmaker AstraZeneca (AZN.L) said on Thursday it would stop developing its drug brazikumab to treat inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis.
Merck will acquire immune-focused Prometheus Biosciences for approximately $10.8 billion, scoring five clinical and pre-clinical candidates for inflammatory bowel and immune-mediated diseases.
In a double data drop yesterday, AbbVie touted two clinical trial wins. Topline data from the Phase III INSPIRE study showed Skyrizi (risankizumab) met its primary and all secondary endpoints in ulcerative colitis and Rinvoq (upadacitinib) aced its Phase II SLEek trial, showing therapeutic potential in systemic lupus erythematosus.
Following a banner year marked by the approval and launch of its diabetes drug Mounjaro, Eli Lilly revealed at the 41st J.P. Morgan Healthcare Conference that it was preparing for another big year.