Opportunity
Federal Register #2026-21718
FDA Announces Priority Review Voucher for ISEMBYLD
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 26, 2026
Identifier
2026-21718
The FDA announced a rare pediatric disease priority review voucher for the approved medicine ISEMBYLD. - Government agency: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). - Notice type: Award announcement, not a procurement solicitation; no goods or services are requested for purchase. - OEM/manufacturer: Scholar Rock, Inc. is identified as the manufacturer of ISEMBYLD (apitegromab-mstn). - Product mentioned: ISEMBYLD injection, indicated for adults and children aged 2 years and older with spinal muscular atrophy who are receiving an SMN2-targeted treatment. No purchase quantity or part number is provided. - Procurement requirements: No purchasable line items, contract value, or performance period are specified.
Description
The Food and Drug Administration announces that it issued a priority review voucher to the sponsor of an approved rare pediatric disease product application. FDA determined that ISEMBYLD (apitegromab-mstn), manufactured by Scholar Rock, Inc., meets the criteria for the voucher. The product was approved on September 11, 2026, and is indicated to treat spinal muscular atrophy in adults and pediatric patients 2 years of age and older who are receiving an SMN2-targeted treatment.