What Was Approved?
On August 19, 2026, the FDA approved Pasatru (garetosmab-grts) for adults with fibrodysplasia ossificans progressiva (FOP).
FOP is a rare genetic disorder in which soft tissues such as muscles, tendons, and ligaments can gradually turn into bone.
What Does Pasatru Do?
Pasatru is approved to help:
- Reduce new heterotopic ossification
- Reduce clinician-assessed disease flare-ups
Heterotopic ossification means abnormal bone formation in tissues where bone normally should not develop.
Who Is This Treatment For?
The approval is for adults with FOP.
Because FOP is extremely rare and treatment can be complex, patients are typically managed by specialists familiar with the condition.
Why Is This Approval Important?
FOP can progressively limit movement as abnormal bone forms throughout the body.
The approval of Pasatru adds another treatment option for adults living with this rare disease. FDA lists Pasatru as one of the novel drug approvals of 2026.
What Should Patients Know?
Patients should discuss:
- Expected benefits
- Possible side effects
- Monitoring requirements
- Other medications
- Pregnancy considerations
with their healthcare team before starting treatment.
Bottom Line
Pasatru (garetosmab-grts) is a newly approved treatment for adults with fibrodysplasia ossificans progressiva.
Its approval provides another option aimed at reducing abnormal bone formation and disease flare-ups in this rare condition.
Sources
- U.S. Food and Drug Administration — Notable Approvals, August 19, 2026.
- U.S. Food and Drug Administration — Novel Drug Approvals for 2026.