Pasatru (garetosmab-grts)

Where it stands

Pasatru (garetosmab-grts), from Regeneron Pharmaceuticals, Inc, is recorded as approved in the US. The FDA approval is dated 2026-08-19 under BLA761508, and the record describes the product as an injectable.

The records leave the therapeutic area and the approved indication blank. This analysis therefore cannot say which patients the product is approved for, the dose or schedule, or any limits on use. Readers should check the approval letter and prescribing information on the FDA's website for those details.

Regulatory pathway and designations

The application is a Biologics License Application (BLA), the US route for biological products. The record flags it as a "New biologic", meaning it is entered as a new product rather than a follow-on or a supplement to an existing license. The "-grts" suffix in the name is the four-letter suffix the FDA assigns to distinguish biologics with the same core name.

The record also lists Priority review. In general, this designation shortens the FDA's target review clock from the standard ten months to six months from filing. It is given to products that the FDA judges could offer a significant improvement in the treatment, diagnosis or prevention of a serious condition. The records do not say what the FDA's reasoning was in this case, whether other expedited designations applied (such as Breakthrough Therapy, Fast Track or orphan status), or what the filing and PDUFA dates were.

The CHMP opinion field is empty. This is expected for a US-only record, because the CHMP is the EMA's scientific committee. No EU status is recorded for this product.

Safety and pharmacovigilance

The records contain no safety information. They give no boxed warning, contraindications, adverse-event profile, REMS, or postmarketing requirements or commitments. Nothing here should be read as a statement about the product's risk profile.

As general context, a newly approved biologic enters routine US pharmacovigilance at approval. This includes adverse-event reporting by the sponsor and through FDA channels, and periodic safety reporting. The FDA can also require postmarketing studies where it judges them necessary. Immunogenicity and injection-related reactions are commonly monitored for injectable biologics. Whether any of this applies to Pasatru must be confirmed from the approved label.

What to watch

The first step is to retrieve the approved label and review documents for BLA761508. They will confirm the indication, the safety language and any postmarketing requirements, none of which are in the current records.

After that, watch for the launch and availability announcements from Regeneron, any postmarketing commitments, and label updates as real-world safety data accumulate. The records show no regulatory filing or decision outside the US, so any ex-US plans would need to come from company communications or later regulatory records.