Clinuvel says real world evidence from the experience of European patients is a key part of the submission it has just made to the US FDA for its ground-breaking phototoxicity therapy, Scenesse (afamelanotide). The company also plans to apply its one-price policy for the product in the US.
Clinuvel has finally completed a new drug application (NDA) filing in the US for its phototoxicity drug Scenesse and expects an approval or complete response letter for the product sometime in 2019. The exact timing will be partly dependent on whether the Food and Drug Administration accepts the company’s request for a priority review.
CEO Philippe Wolgen said the company had taken advantage of the FDA’s increasing openness to real world evidence (RWE) by...
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
