Requests that the FDA refrain from approving any analog of human C-type natriuretic peptide as a treatment for achondroplasia until the orphan-drug exclusivities currently protecting BioMarin’s Voxzogo (vosoritide) expire. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-1704

Requests that the FDA refrain from approving any analog of human C-type natriuretic peptide as a treatment for achondroplasia until the orphan-drug exclusivities currently protecting BioMarin’s Voxzogo (vosoritide) expire.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensJun 13, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA OC to Sidley Austin LLP	Mar 2, 2026	--

Comment Statistics

Total Comments

Keywords

Citizen Petition

Sidley Austin LLP

refrain from approving any CNP analog

as a treatment for achondroplasia in any

pediatric patients until November 19 2028

refrain from approving any

CNP analog as a treatment for achondroplasia

Data from Regulations.gov