Multiple Sclerosis Research Repository

1. From Ocrevus Pharmacology Review (Reference ID: 4015041):

-3 pre-term births in the high dose OCR group; no pre-term births observed in any other group (p 98)

-Stillbirths occurred in 2 low dose and 1 high dose animal; no stillbirths in control group; a relationship to the test article cannot be ruled out since all stillbirths occurred only in dams that were dosed with ocrelizumab; the sponsor concluded that due to the lack of an increase in incidence with dose, the stillbirths were not related to the test article (p 98)

-the incidence of embryofetal loss in the HD group appears to be increased relative to the control and LD groups (p 97-98)

-a dose-related effect of reduced birth weight was observed as summarized in the table below (p 99)