Request that the FDA withdraw or suspend approval and acceptance of the fenebrutinib FENtrepid clinical trial for primary progressive multiple sclerosis (PPMS) to the extent that it relies on ocrelizumab (Ocrevus) as an active control; and require redesign of the trial to use an appropriate comparator | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-0776

Request that the FDA withdraw or suspend approval and acceptance of the fenebrutinib FENtrepid clinical trial for primary progressive multiple sclerosis (PPMS) to the extent that it relies on ocrelizumab (Ocrevus) as an active control; and require redesign of the trial to use an appropriate comparator

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensJan 27, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response from FDA CDER to Kaylin Bower	Jul 22, 2026	--

Keywords

CDER

Citizen Petition

withdraw or suspend FDA approval

and acceptance of the fenebrutinib FENtrepid

clinical trial for primary progressive

multiple sclerosis (PPMS) to the extent that

it relies on ocrelizumab (Ocrevus) as an

active control and require redesign of

Data from Regulations.gov