Review divisions strongly encouraged filing of both the Novartis and Biogen drugs despite trials that missed their primary endpoints; with the heart failure drug, the agency took a more even-handed approach to presenting the data and was commended for its willingness to look beyond the narrowly missed p-value, in contrast to the barrage of criticism it faced with the Alzheimer’s drug.
The US Food and Drug Administration advisory committee review of a new heart failure indication for Novartis AG’s Entresto (sacubitril/valsartan) had the potential to be a repeat of the panel meeting on Biogen, Inc.’s Alzheimer’s drug aducanumab more than a month earlier.
As was the case with aducanumb, Novartis was coming to the panel with a trial that missed its primary endpoint....
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The US FDA’s unprecedented publication of 89 recent CRLs for unapproved products comes with a promise to release future letters more promptly.
US FDA's regulatory flexibility for rare diseases is newly enshrined in the FDA's "Rare Disease Evidence Principles," but upcoming goal dates include some real-world examples of challenging orphan applications.
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Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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.
The FDA could act on 17 applications, including 10 novel agents, during August. Only one would be a second-cycle review.
