Albeit with complaints and provisos, the U.S. FDA’s Antimicrobial Drugs Advisory Committee (ADAC) rubber-stamped Cidara Therapeutics Inc.’s rezafungin, an injectable treatment for candidemia and invasive candidiasis (IC) in adults. Panelists were asked to vote on a single question: “Is the overall benefit-risk assessment favorable for the use of rezafungin for treatment of candidemia/IC in adults with limited or no alternative treatment options?” The balloting turned out 14 yes, one no.
Next week, Cidara Therapeutics Inc. will make its case for rezafungin, an injectable treatment for candidemia and invasive candidiasis in adults, before the U.S. FDA’s Antimicrobial Drugs Advisory Committee. When it convenes Jan. 24, the adcom will vote either yes or no if it believes the overall benefit-risk assessment is favorable for the use of rezafungin for treating candidemia/invasive candidiasis in adults with limited or no alternative treatment options.
In the wake of ongoing criticism over the U.S. FDA’s 2021 accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, the percentage of novel drugs receiving accelerated approval last year was the lowest it’s been since 2018.
As the Feb. 28, 2023 PDUFA date for the compound nears, Cytokinetics Inc. CEO Robert Blum insisted that his firm is not mulling withdrawal of the marketing application for heart failure drug omecamtiv mecarbil, nor is the company now considering another study, after an unfavorable vote on the drug Dec. 13 by the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee.
Even though Cytokinetics Inc. received applause for testing its heart failure drug, omecamtiv mecarbil, in the second largest global heart disease clinical trial ever, the drug didn’t get a standing ovation from the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Dec. 13.
What could be Cytokinetics Inc.’s first approved drug will take center stage Dec. 13 at a meeting of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee. But judging from the FDA’s briefing document for the meeting, the spotlight on the heart failure drug, omecamtiv mecarbil, could be harsh.
Ardelyx Inc. could have a rocky row to hoe when it makes its case for tenapanor, as a hyperphosphatemia therapy in adults with chronic kidney disease, before the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee Nov. 16. The big question facing the adcom is whether the change in baseline serum phosphorous levels achieved by the drug is clinically meaningful. Clearly, FDA reviewers don’t think so, as that question already has resulted in delayed PDUFA dates, a complete response letter and two formal dispute resolution requests.
Veru Pharmaceuticals Inc.’s COVID-19 therapy VERU-111 (sabizabulin) failed to win full support from the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee, which was asked to decide about endorsing the firm’s request for an emergency use authorization to market the drug.
Briefing documents related to the Nov. 9 meeting of the U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee augur well for Veru Pharmaceuticals Inc.’s request for an emergency use authorization to market VERU-111 (sabizabulin) as a treatment for COVID-19.
Briefing documents related to the Oct. 28 meeting of the Oncologic Drugs Advisory Committee (ODAC) to deliberate over Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) took aim at the company’s ongoing, pivotal experiment called Study 101, data from which the company highlighted in early October.
