Shots:
- The US FDA has approved Pasatru (garetosmab-grts) to reduce the formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP), based on the P-III OPTIMA trial assessing 10 mg/kg (n=23) & 3 mg/kg (n=19) Pasatru vs PBO (n=21)
- At Wk. 56, Pasatru 10 mg/kg reduced the total number of new HO lesions by 90% vs PBO (2 vs 19 lesions), while the 3 mg/kg dose reduced lesions by 94% (1 vs 19 lesions), as assessed by CT scan
- At Wk. 56, clinician-assessed flare-ups were reduced by 88% with Pasatru 10 mg/kg (9 vs 66 events) and by 15% with 3 mg/kg (53 vs 66 events) vs PBO. The proportion of patients reporting flare-ups through Wk 56 did not differ significantly between the PBO and Pasatru treatment groups.
Ref: Regeneron| Image: Regeneron | Press Release
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