Vumerity

Neurology· 261 cited findings· 1 source document

What the regulatory reviews say

Vumerity (ALKS 8700) is a drug approved for the treatment of relapsing forms of multiple sclerosis. The application for approval, NDA 211855, was submitted on December 13, 2018, and received approval on October 10, 2019. The regulatory action recommended was Approval, under an Application Type of 505(b)(2).

In efficacy studies, ALKS 8700 demonstrated an Annualized Relapse Rate (ARR) of 0.17. Reductions in ARR ranged from 29% to 61% across various analyses, with a 46% reduction in ARR for relapsing-remitting multiple sclerosis (RMS). Disability progression reduction was observed at 24% in primary progressive MS. Safety data indicated 0 deaths and 0 serious adverse events (SAE). Total treatment-emergent adverse events (TEAEs) were 84, with 72 classified as mild and 12 as moderate. Flushing was reported in 13 subjects receiving ALKS8700 DR, compared to 1 subject in the placebo group.

Key figures — cited to the source page

Annualized relapse rate (ARR) with ALKS 8700	0.17	Biogen Inc. — Vumerity FDA Review, p.56
ARR reduction (RMS)	46%	Biogen Inc. — Vumerity FDA Review, p.17
Disability progression reduction (primary progressive MS)	24%	Biogen Inc. — Vumerity FDA Review, p.17
Deaths	0	Biogen Inc. — Vumerity FDA Review, p.48
Serious adverse events (SAE)	0	Biogen Inc. — Vumerity FDA Review, p.48
Flushing (ALKS8700 DR)	13	Biogen Inc. — Vumerity FDA Review, p.48
Proposed Indication	Relapsing forms of multiple sclerosis	Biogen Inc. — Vumerity FDA Review, p.2
Recommendation on Regulatory Action	Approval	Biogen Inc. — Vumerity FDA Review, p.2

Source documents

Biogen Inc. — Vumerity FDA Review (NDA211855, ORIG 1, 2019) (2019)

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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.