Label offers little differentiation from Tecfidera, but head-to-head trial with custom-designed patient-reported outcome could make case for gastrointestinal tolerability advantage.
US labeling for Biogen Inc. and Alkermes PLC’s Vumerity (diroximel fumarate) does not address the gastrointestinal tolerability advantage over Biogen’s Tecfidera (dimethyl fumarate) that the companies have long said is the rationale for developing the new multiple sclerosis therapy.
The Food and Drug Administration granted full approval to the Vumerity NDA on 29 October 2019, shortly after issuing a...
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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.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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