The Food and Drug Administration on Tuesday accredited a brand new drug to deal with a vaginal yeast an infection that’s particularly frequent in ladies who’re pregnant, utilizing contraception tablets or taking antibiotics.
The drug, Brexafemme (ibrexafungerp) made by SCYNEXIS, is a one-day oral remedy and the primary of a brand new class of triterpenoid antifungal medicine. The firm mentioned the brand new drug kills candida — the yeast that may trigger an an infection.
The customary oral treatment, Diflucan (fluconazole), inhibits the expansion of yeast however doesn’t kill it.
But the remedy almost definitely wouldn’t be prescribed broadly at first for frequent vaginal yeast infections. Dr. David Angulo, the corporate’s chief medical officer, estimated that the checklist value of the drug would vary from $350 to $450 for the four-tablet remedy. By comparability, GoodRx lists the typical retail value of fluconazole as $29.81.
He mentioned Brexafemme was accredited as a first-line remedy, however is also prescribed for sufferers whose infections don’t clear up simply.
“There has been nothing new that can be provided to patients who can’t tolerate it, don’t respond well or develop resistance,” Dr. Angulo mentioned.
Dr. Sumathi Nambiar, director of the F.D.A.’s division of anti-infectives mentioned: “This approval for a new antifungal drug provides an additional treatment option for patients with vulvovaginal candidiasis, or vaginal or vulvar yeast infections, and represents another step forward in the F.D.A.’s overall efforts to ensure safe and effective antifungal drugs are available to patients.”
Dr. Denise Jamieson, chair of gynecology and obstetrics at Emory University School of Medicine, mentioned she wasn’t certain the brand new drug was wanted.
“I don’t see a tremendous amount of resistance,” she mentioned. “I can’t really comment on whether this is going to be a large addition or not. It’s always helpful to have another option, and then you have to consider things like cost and tolerability.”
According to Dr. Angulo, one scientific trial used to assist the applying confirmed 50 p.c efficacy — that means full decision of all indicators and signs — at 10 days after remedy and 60 p.c 25 days after remedy. The different trial confirmed 64 p.c efficacy at day 10 and 73 p.c at day 25.
Dr. Michael Carome, director of Public Citizen’s Health Research Group, was not impressed by the F.D.A.’s approval of Brexafemme.
“This drug is not necessary and few women should need it,” Dr. Carome mentioned. “Fluconazole is available at very low cost and in general is very effective. The cost of this is just outrageous.”
The F.D.A. is requiring SCYNEXIS to conduct a number of post-market research, together with one to assess the dangers to pregnant ladies, the growing fetus and newborns; and one other to examine how a lot of the product goes into the breast milk of lactating ladies.
The drug will go on sale later this 12 months.