Fierce Biotech

Roche reports another phase 3 multiple sclerosis win, but deaths add to safety questions

The Swiss drugmaker reported a phase 3 win for fenebrutinib over Sanofi's Aubagio in RMS in November. In that study, Roche linked its drug candidate to a 59% reduction in the annualized relapse rate ...
PharmiWeb

Genentech's Fenebrutinib Confirms Its Potential as First and Only BTK Inhibitor for Relapsing and Primary Progressive MS in Third Positive Phase III Study (FENhance 1)

FENhance 1 met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses by 51% compared to teriflunomide in relapsing multiple sclerosis (RMS), consistent with ...
Morningstar

Genentech’s Fenebrutinib Is the First Investigational Medicine in Over a Decade That Reduces Disability Progression in Primary Progressive Multiple Sclerosis (PPMS)

Genentech’s Fenebrutinib Is the First Investigational Medicine in Over a Decade That Reduces Disability Progression in Primary Progressive Multiple Sclerosis (PPMS) – Late-breaking Phase III FENtrepid ...
Nasdaq

Press Release: Sanofi provides update on tolebrutinib in primary progressive multiple sclerosis

PERSEUS phase 3 study in primary progressive multiple sclerosis did not meet its primary endpoint in delaying time to onset of 6-month composite confirmed disability progression compared to placebo ...
Medscape

Trials Offer Mixed Results on BTK Potential for Primary Progressive Multiple Sclerosis

SAN DIEGO — Results from two phase 3 trials offer mixed findings on the potential of experimental Bruton tyrosine kinase (BTK) inhibitors for primary progressive multiple sclerosis (PPMS). Findings ...
Seeking Alpha

Genentech’s Fenebrutinib Shows Unprecedented Positive Phase III Results as the Potential First and Only BTK Inhibitor in Both Relapsing and Primary Progressive Multiple Sclerosis

- The first (FENhance 2) of two pivotal RMS studies met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses compared to teriflunomide - - In a pivotal PPMS study ...
Becker's Hospital Review

U.S. FDA grants Breakthrough Therapy Designation for Roche’s investigational medicine ocrelizumab in primary progressive multiple sclerosis

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (OCREVUSTM ...
Business Wire

Genentech’s Fenebrutinib Is the First Investigational Medicine in Over a Decade That Reduces Disability Progression in Primary Progressive Multiple Sclerosis (PPMS)

– Late-breaking Phase III FENtrepid results presented at ACTRIMS show investigational fenebrutinib met its primary endpoint of non-inferiority compared to the current standard of care, Ocrevus, in ...
Rutland Herald

Genentech’s Fenebrutinib Is the First Investigational Medicine in Over a Decade That Reduces Disability Progression in Primary Progressive Multiple Sclerosis (PPMS)

Approximately 85% of people with multiple sclerosis have a relapsing form of the disease (RMS) characterized by relapses and also worsening disability over time. Primary progressive multiple sclerosis ...