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Denali CEO’s ‘greatest professional moment’ arrives as rare disease drug launches

Denali CEO’s ‘greatest professional moment’ arrives as rare disease drug launches

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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

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Why key opinion leader enthusiasm often doesn’t predict future commercial success

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While prominent physicians can provide companies with valuable guidance during development, their perspective is limited when it comes to projecting how well or how readily a new product will be adopted. Here’s how to perform rigorous commercial diligence.

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#AAN26: Roche’s multiple sclerosis pill delays relapse, but liver toxicity could need monitoring

#AAN26: Roche’s multiple sclerosis pill delays relapse, but liver toxicity could need monitoring

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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

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STAT+: With successful trials, Roche takes its MS drug to regulators, but safety questions loom

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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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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