Drug Review

<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.

Non-Japanese firms without offices in the country may submit documents for approval filings in English, subject to certain conditions.

The Pink Sheet Drug Review Profile explores the US FDA’s approval of vadadustat to treat anemia in chronic kidney disease patients on dialysis. A complete response letter cited the risk of drug-induced liver injury, but postmarketing data from Japan reassured reviewers.

The Pink Sheet’s Drug Review Profile looks at the timeline behind the development and US FDA approval of Akebia’s Vafseo, a treatment for anemia in chronic kidney disease patients on dialysis.

Under the new drug approval innovation measures, Korea will cut the review and approval period of new drugs to 295 days from 420 days and increase the number of expert reviewers to enhance review capabilities.

A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.  

A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.

Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process. 

The Malaysian agency’s drug review mechanism that relies on assessments by overseas regulators is now being tested for applications seeking approval for additional indications.

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered. 

Principal deputy commissioner Bumpus agrees with advisory committee findings that safety issues with ITCA 650 preclude approval, regardless of comparisons to other diabetes treatments. Final order caps a nearly eight-year regulatory saga that has grown increasingly rancorous.

Conflicted experts should be allowed to participate as nonvoting members and panels should take a benefit-risk vote on product-specific applications, the majority of respondents said in a survey conducted by 3D Communications.

While the drug regulator has approved Eisai/Biogen’s early Alzheimer’s disease treatment, the health technology assessment institute is worried that its benefits are too small to justify its costs – a concern that Eisai has pledged to address.

Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.

The MHRA says that having a complete picture of all upcoming filings will allow it to ensure “consistent and predictable” timelines for assessments and identify “potentially transformative technologies” at an early stage.

Alvotech and its partners Advanz and Biogaran have welcomed acceptance in Europe for the Icelandic firm’s filing for a proposed biosimilar to Eylea 2mg, as another player makes its move.

The 9 September meeting on Iterum Therapeutics' oral sulopenem product for uncomplicated urinary tract infections marks the first fully in-person advisory committee drug review since the COVID-19 pandemic hit in early 2020.

The European Medicines Agency has started reviewing new marketing applications for 10 products, including Blenrep, GSK’s previously approved multiple myeloma drug that was withdrawn from the market, and vimseltinib, which could become the EU’s first oral treatment approved for TGCT.

With monographs@FDA portal down, agency moves to NextGen and extends comment period through 27 September for first OTC monograph change it proposed using its overhauled program other than 32 monographs finalizations required in 2020 legislation authorizing overhaul.