Preterm birth prevention drug should come off the market to ensure the accelerated approval pathway does not operate as a lower approval standard, agency says; proposed withdrawal comes almost a year after an advisory committee split on the question of whether Makena should stay on the market in light of delayed, and ultimately unsuccessful, confirmatory study.
Citing a failed confirmatory trial as well as the “integrity” of the accelerated approval process, the US Food and Drug Administration is seeking to remove AMAG Pharmaceuticals Inc.'s preterm birth prevention drug Makena (hydroxyprogesterone caproate) from the market.
On 5 October, the Center for Drug Evaluation and Research announced its proposal to withdraw Makena, along with its generic...
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 FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
<p>Executive Summary</p> <p>Zanidatamab, Jazz and BeiGene’s investigational treatment for biliary tract cancer, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.</p>
<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>
