Pasatru (garetosmab) for Fibrodysplasia ossificans progressiva (FOP)
What the FDA decided
The FDA approved Regeneron's BLA for Pasatru (garetosmab) in Fibrodysplasia ossificans progressiva (FOP). Approved for adults with FOP. Sohonos, approved in 2023, also covers adults, so Pasatru gave adults a second option.
Who this decision matters to
Fibrodysplasia Ossificans Progressiva (FOP) is an extremely rare genetic disorder characterized by progressive heterotopic ossification, where soft tissues (muscles, tendons, ligaments) gradually transform into bone. This leads to progressive immobility and severe physical disability. FOP is caused by mutations in the ACVR1 gene, and nearly all cases involve a single mutation (c.617G>A).
Prevalence: Extremely rare, about 1 in 1 million to 1 in 2 million people worldwide. See our full Fibrodysplasia Ossificans Progressiva page for current treatments, recruiting trials, and community resources.
Where Fibrodysplasia Ossificans Progressiva treatment stands today
Read our full Fibrodysplasia Ossificans Progressiva treatment summary
Research in Fibrodysplasia Ossificans Progressiva is advancing through ALK2 inhibitors targeting the specific ACVR1 mutation that causes the disease, along with approaches to block BMP signaling pathways that drive abnormal bone formation. Clinical trials measure treatment success through imaging tracking ossification progression, assessments of functional mobility, and importantly, reductions in flare frequency and severity that cause pain and rapid progression.
Quality of life improvements matter significantly. Your genetic confirmation of the ACVR1 mutation guides therapy selection.
Baseline imaging documents disease extent and helps track progression. Trials track biomarkers including alkaline phosphatase that reflect ossification activity.
Pain management and reducing inflammation during flares are equally important as slowing bone formation. Your rheumatologist or genetics specialist experienced in FOP can help identify appropriate trials and discuss the exciting potential of ALK2 inhibitors.
The FDA has approved 3 medicines for FOP: Sohonos (palovarotene) capsules on August 16, 2023 for adults and for girls 8 and older and boys 10 and older, Pasatru (garetosmab) infusions on August 19, 2026 for adults, and Atebrioz (zilurgisertib) on September 25, 2026 for people 12 and older. No trial has compared them with each other, so ask your FOP specialist whether an approved medicine or a clinical trial is the better fit for you.
The Fibrodysplasia Ossificans Progressiva page has every treatment and trial →Meanwhile, 5 Fibrodysplasia Ossificans Progressiva trials are recruiting
Whatever the FDA decides here, research on Fibrodysplasia Ossificans Progressiva does not stop. A few currently enrolling studies, US sites first:
You'll hear about future FDA decisions and new recruiting trials for Fibrodysplasia Ossificans Progressiva. Unsubscribe anytime.
Frequently asked questions
Has the FDA decided on Pasatru?
The FDA has already decided. It approved the application.
Details: the outcome and what it means are at the top of this page.
Source: Regeneron press release
What was Pasatru approved for?
The FDA approved Regeneron's BLA for Pasatru in Fibrodysplasia ossificans progressiva (FOP).
What to know: Approved for adults with FOP. Sohonos, approved in 2023, also covers adults, so Pasatru gave adults a second option.
Is there already an FDA-approved treatment for Fibrodysplasia Ossificans Progressiva?
Yes. Trial Friend's drug list includes 3 FDA-approved drugs for Fibrodysplasia Ossificans Progressiva.
Approved: Sohonos (palovarotene), Atebrioz (zilurgisertib), Pasatru (garetosmab-grts).
Check: the Fibrodysplasia Ossificans Progressiva page also searches FDA drug labels for approved treatments.
How much will Pasatru cost?
Trial Friend does not list a price for Pasatru. What you pay depends on your insurance and on help from the drugmaker or a charity fund.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Pasatru decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Regeneron press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.