Immunology and inflammation
At the heart of the licensing deal is CUE-501, a bispecific molecule that can selectively deplete B cells to address autoimmune and inflammatory conditions.
Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for Regeneron, one with partner Sanofi.
Leerink analysts noted, however, that Uplizna’s slow onset of therapeutic efficacy compares unfavorably to would-be competitors in generalized myasthenia gravis.
Wegovy and Zepbound are just the latest drug dyads to face-off in the competitive pharma market, continuing a legacy of rivalry that includes blockbuster drugs Keytruda, Humira and Eliquis.
Merida is working on a selective therapy for Graves’ disease, leveraging targeted therapies that can deplete disease-causing autoantibodies.
The FDA has asked for another well-controlled trial to establish the efficacy of reproxalap in dry eye disease.
In the Phase III MITIGATE trial, Uplizna cut IgG4-related disease flares by 87% versus placebo.
In the coming two weeks, the FDA is expected to announce three big decisions, including one for a dry eye disease therapy.
Merck’s new formulation of the mega-blockbuster Keytruda, made in collaboration with Alteogen, could help to keep the drug’s patent cliff at bay.
AbbVie’s Humira was the top-selling drug in the world for many years. Now, its sales are eroding as doctors switch to biosimilars and new options enter the market.
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