Amicus plans to file migalastat for Fabry disease in the US in the fourth quarter, after FDA gave the greenlight, reversing a decision last year to require an additional Phase III study. Additional information includes European submission data and post-launch RWE.
It's not often that FDA backtracks on a decision, but in a surprising turn of events, the agency has reversed a decision on Amicus Therapeutics Inc.'s oral therapy for Fabry disease, migalastat, agreeing the company can submit an NDA for accelerated review based on existing data.
The company announced July 11 that it now plans to file an NDA for migalastat in the fourth quarter, following...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
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<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
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<p>Executive Summary</p> This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
