Phase III
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Roche’s fenebrutinib this week scored a mid-stage win in relapsing multiple sclerosis, while Sanofi’s tolebrutinib met the primary endpoint in a Phase III trial for progressive MS but flopped in two late-stage relapsing MS studies.
If approved in chronic obstructive pulmonary disease, Nucala will compete with Verona’s Ohtuvayre and—pending a potential approval later this month—Sanofi and Regeneron’s blockbuster Dupixent.
Eli Lilly’s weekly insulin injection efsitora alfa secured two late-stage victories on Thursday in a potential blow to rival Novo Nordisk, which in July failed to secure the FDA’s approval for its basal insulin icodec.
A broad indication for MariTide could help Amgen secure Medicare coverage for the treatment following FDA approval, CEO Robert Bradway said at Wednesday’s Morgan Stanley Global Healthcare Conference.
The investigational injection fosgonimeton appeared to have better efficacy in patients with more severe disease, according to post-hoc subgroup analyses, though none resulted in statistically significant effects.
Bayer’s Kerendia, at the center of a $3 billion sales forecast, reduced the risk of cardiovascular death and heart failure in a Phase III trial.
The BTK inhibitor showed promise in non-relapsing secondary progressive multiple sclerosis but not relapsing MS. The company said it plans to apply for approval for the former “as soon as possible.”
Despite the added survival benefit for its drug, Alnylam still faces steep competition from Pfizer, whose ATTR-CM therapies have become established treatment options.
The pharma continued its clinical losing streak on Thursday with the announcement that it is discontinuing late-stage studies of the anti-PD-1 therapy in non-small cell lung cancer and cutaneous squamous cell carcinoma.
Armed with new late-stage data on reducing low-density lipoprotein cholesterol, Novartis is positioning its siRNA therapy Leqvio as a preventive treatment for atherosclerotic cardiovascular disease.
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