Scynexis receives the green light from the FDA for the future blockbuster of vaginal yeast infections

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Armed with approval in a prominent state with few attractive treatment options, Scynexis is preparing to take a giant leap into women’s health.

The FDA this week approved Scynexis Ibrexafungerp tablets, now called Brexafemme, for the treatment of vaginal yeast infections. The green light marks the first approval of a new class of antifungal drugs in more than 20 years and brings 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 a lifetime. Nevertheless, innovation has stagnated since the late 1990s, the analysts at Cantor Fitzgerald wrote to their customers on Wednesday.

Fluconazole, sold by Pfizer as Diflucan, is the only other oral antifungal drug approved in the United States for the treatment of vaginal yeast infections.

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 and the “growing interest of major pharmaceutical companies in the antifungal market,” Brexafemme could have annual sales of over $ 1 billion, according to Cantor Fitzgerald’s team.

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The FDA has approved Brexafemme based on the results of two Phase 3 studies. Last April, the company released data from its second late-stage study, Vanish-306, which showed that 63.3% of patients on Brexafemme achieved clinical cure status, based on a test performed 10 days after starting treatment. Meanwhile, 73.9% of the patients had completely resolved their symptoms by a follow-up examination after 25 days.

Scynaxis submitted its new drug application in mid-October and received a priority review in December. The FDA previously blessed the drug with Fast Track status and awarded Brexafemme a Qualified Infectious Disease Product (QIDP) label as a great boon to Scynexis. With this QDIP designation, Scynexis expects Brexafemme to have 10 years of market exclusivity in the USA

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Scynexis plans to launch Brexafemme in the second half of the year. To launch it, it partnered with contract marketer Amplity Health, which signed a five-year contract with Scynexis in February to use its resources for sales reps, remote engagement, training, market access and more.

Elsewhere in its portfolio, Scynexis is developing Ibrexafungerp for the prevention of recurring vaginal yeast infections and for the treatment of life-threatening, invasive fungal infections in hospital patients.



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