Scynexis clinches FDA green light for vaginal yeast infection blockbuster-to-be

Scynexis next year plans to submit a supplemental application for Brexafemme to prevent recurrent vaginal yeast infections. (Scynexis)

Armed with an approval in a prominent condition with few attractive treatment options, Scynexis is preparing to make a big splash in women's health. 

The FDA this week approved Scynexis’ ibrexafungerp tablets, now christened Brexafemme, to treat vaginal yeast infections. The green light marks the first approval in a new class of antifungal drugs in more than 20 years and propels Scynexis into the commercial realm with a potential blockbuster in tow.

Vaginal yeast infection, also known as vulvovaginal candidiasis, is incredibly common, affecting around 70% to 75% of women at least once in their lifetime. Still, innovation has been stagnant since the late 1990s, Cantor Fitzgerald analysts wrote to clients Wednesday.

Fluconazole, which is sold by Pfizer as Diflucan, is the only other oral antifungal approved to treat vaginal yeast infection in the U.S. It has “typically accounted” for more than 90% of yeast infection prescriptions each year, Scynexis said in a release.

Enter Brexafemme, a once-daily oral option that, unlike fluconazole and other azoles, kills the fungal cells behind the infection. Given the drug’s differentiated mechanism of action, not to mention an “increasing interest by large pharma in the antifungal space,” Brexafemme could surpass $1 billion in annual sales, the Cantor Fitzgerald team figures.

RELATED: As Organon charts post-spinoff future, Merck's $9B cash infusion could fund big M&A score

The FDA approved Brexafemme based on the results of two phase 3 trials. Last April, the company unveiled data from its second late-stage trial, Vanish-306, which showed that 63.3% of patients on Brexafemme achieved clinical cure status based on a test given 10 days after starting treatment. Meanwhile, 73.9% of patients had their symptoms resolved completely by a follow-up visit at the 25-day mark.  

Scynexis submitted its new drug application in mid-October and snared a priority review in December. The FDA previously blessed the drug with fast track designation and, in a major boon for Scynexis, granted Brexafemme a Qualified Infectious Disease Product (QIDP) tag. With that QDIP designation, Scynexis expects Brexafemme to receive 10 years of market exclusivity in the U.S.

RELATED: Merck pulls back the curtain on Organon with declining women's health portfolio but determined women in C-suite, board

Scynexis aims to launch Brexafemme in the second half of the year. For the launch, it's teamed up with contract commercialization organization Amplity Health, which inked a five-year deal with Scynexis in February to deploy its resources for sales force, remote engagement, training, market access and more.

The company is still tuning its commercial pitch and hasn't unveiled pricing details yet. It plans to share more about its plans at an upcoming investor event late this month, Scynexis CEO Marco Taglietti, M.D., said over email. The company is currently planning to use a mix of digital and in-person outreach to get the word out to doctors who specialize in women's health, including obstetrician-gynecologists and nurse practitioners, Taglietti added. 

Elsewhere in its portfolio, Scynexis is developing ibrexafungerp to prevent recurrent vaginal yeast infections and to treat life-threatening, invasive fungal infections in hospital patients.

"This is a breakthrough not only for women’s health but for the overall antifungal space," Taglietti said via email. The company sees its Brexafemme approval as a "major step" on its quest to establish a "blockbuster antifungal franchise."

Editor's note: This story has been updated with additional comments from Scynexis.