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FDA approves Regeneron's Pasatru for adults with fibrodysplasia ossificans progressiva
The approval follows a 56-week Phase 3 trial in 63 adults where the 3-milligram-per-kilogram dose cut new abnormal bone lesions by 94% versus placebo.
Yahoo Finance reports that the FDA has approved Regeneron Pharmaceuticals' Pasatru, with the generic name garetosmab, for adults with fibrodysplasia ossificans progressiva, an ultra-rare genetic disorder where bone forms inside muscles, tendons, and ligaments and progressively restricts movement.
The outlet said the approval is based on a 56-week Phase 3 trial involving 63 adults. In that study, the approved 3-milligram-per-kilogram dose reduced the number of new abnormal bone lesions by 94% compared with placebo.
Yahoo Finance also noted that Regeneron previously paused an earlier study in 2020 after five patients died during an open-label portion where all participants were receiving active treatment. The later published analysis found the relationship to treatment appeared unlikely, though causality could not be ruled out.
According to the piece, Pasatru represents a regulatory and scientific win for Regeneron, but earnings impact may be limited by the very small addressable market. The article adds that Regeneron reported second-quarter revenue of $4.29 billion, up 17%, and non-GAAP diluted EPS of $14.29, while existing franchises such as Dupixent and U.S. Eylea HD contribute substantially to results.