FDA panel recommends rezafungin as new Candida treatment

News brief

The Food and Drug Administration (FDA) antimicrobial drugs advisory committee yesterday recommended the approval of rezafungin for the treatment of candidemia and invasive candidiasis in adults, the first new drug to treat the conditions in over a decade.

Cidara Therapeutics, based in San Diego, developed the drug and has signed a licensing agreement with Melinta Therapeutics to market and distribute rezafungin—an echinocandin antifungal—in the United States. The FDA committee's recommendation passed by a 14-to-1 vote. The committee's vote isn't binding, but the FDA often accepts the recommendations of its advisory groups when making its approval decisions. Cidara submitted the drug for review last July, and the FDA has granted it a priority review.

Jeffrey Stein, PhD, Cidara's president and chief executive office, said in a company statement that the committee's recommendation is a significant step toward the goal of providing a once-weekly treatment option for patients who have invasive Candida infections.

The FDA panel based its recommendation on encouraging phase 3 and phase 2 trials, along with extensive nonclinical findings. When given once-weekly to patients, rezafungin demonstrated statistical noninferiority when compared to caspofungin, the current standard of care that is given once daily. The results of the studies met the primary end points defined by the FDA and the European Medicines Agency.

Global flu activity declines further amid rising H1N1 rates

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Lisa Schnirring

Global flu levels are decreasing, but remain elevated due to ongoing activity in the Northern Hemisphere, the World Health Organization (WHO) said this week in an update, which covers the last week of December and the first week of January. In another development, proportions of 2009 H1N1 viruses nosed ahead of the H3N2 strain.

In North America, flu levels are now at or below levels typically seen at this time of the year. Europe's activity is decreasing but is still above the regional threshold, with similar proportions of H1N1 and H3N2 viruses circulating.

In Western Asia, activity rose in some countries such as Israel, and in East Asia, Mongolia and South Korea continue to report elevated illness levels. Meanwhile, Southeast Asia is experiencing elevated levels of influenza B activity, mainly in Malaysia.

Tropical parts of Africa and South America are seeing low overall activity, but flu positivity was reported as moderate in Ecuador.

Of respiratory samples that tested positive for flu at national labs during the reporting period, 93.7% were influenza A. Of subtyped influenza A samples, 51.9% were H1N1 and 48.1% were H3N2. Of characterized influenza B viruses, all belonged to the Victoria lineage.