After receiving the FDA’s greenlight for Hunter syndrome drug Avlayah, Denali Therapeutics CEO Ryan Watts saw the culmination of 20 years of hard work unraveling the mysteries of the blood-brain barrier.​ ​Read More

Roche’s multiple sclerosis pill more than doubled patients’ relapse-free interval compared with Sanofi’s marketed MS pill Aubagio, according to data presented late on Tuesday.

The drug, a BTK inhibitor called fenebrutinib, demonstrated “the lowest relapse …​ ​Read More

The Swiss drugmaker Roche on Tuesday presented the latest data for its experimental multiple sclerosis drug, setting the stage for the company to seek approval for a medicine that it believes can cut relapse rates and slow the progressive disability the disease causes.  

Now the test is whether the drug, called fenebrutinib, can win the regulatory green light.

While three late-stage trials of the drug have shown it to be effective, analysts have homed in on some potentially worrying liver safety signals, an issue that previously prompted the Food and Drug Administration to reject an MS therapy developed by Sanofi. In data released Tuesday, researchers also disclosed that there were two drug-related deaths among patients who took fenebrutinib.  

Continue to STAT+ to read the full story…

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