Covis says it respects advisory committee vote at October public hearing favoring withdrawal; proposal comes four years after failure of the PROLONG confirmatory trial to confirm clinical benefit in preventing preterm birth.
Covis Pharma said it will “voluntarily withdraw” the preterm birth prevention drug Makena (hydroxyprogesterone caproate injection, also known as 17-OHPC or 17-P) from the US market, a decision that follows a multi-year fight with the FDA’s Center for Drug Evaluation and Research and an overwhelmingly negative advisory committee vote at an October 2022 public hearing.
However, the company requests the agency grant “an orderly wind-down” that would allow at least 21 weeks from the time...
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>
