Express FDA approves the 25th new drug this year, the speed of approval hit a record high over the same period

▎ WuXi AppTec content team editor On June 2, 2021, Scinexis announced that the US FDA has approved the innovative oral glucan synthase inhibitor Brexafemme (ibrexafungerp) to be marketed for the treatment of vulvovaginal candidiasis (VVC, also known as For vaginal yeast infections), Brexafemme belongs to the "first-in-class" triterpene antifungal agent.

The press release pointed out that Brexafemme is the first innovative antifungal drug type approved in more than 20 years and the first non-azole therapy for the treatment of vaginal yeast infections.

It is worth mentioning that Hausen Pharmaceuticals has signed a strategic cooperation agreement with Scinexis to obtain the exclusive rights to develop and commercialize ibrexafungerp in Greater China.

This is also the 25th new drug approved by the US FDA this year, surpassing the total number of new drugs approved in the first half of last year (24 models) and setting a new high in the first half of the past 10 years.

Related reading: FDA set three "new highs" in new drug approvals in the first half of the year.
What trends do they represent in drug development? Its approval is based on the positive results of two phase 3 clinical studies, which showed that the drug once a day orally once a day showed significant efficacy and good tolerability in patients with VVC.

After 10 days of treatment, 63.
3% of the patients reached the primary endpoint of clinical cure, 58.
5% of the patients reached the secondary endpoint of mycological eradication, and 72.
3% of patients achieved clinical improvement.

 VVC is an inflammatory disease caused by fungal infection.
The main pathogenic bacteria is Candida albicans.

Approximately 75% of women will suffer from VVC in their lifetime, and 40% to 50% will relapse again.

It can be clinically manifested as genital itching, burning pain, increased leucorrhea, painful urination, and pain during intercourse, which seriously affect the quality of life.

The current common treatments are topical or oral azole antifungal drugs, and their clinical application is limited.
Therefore, patients have major medical needs for a new generation of safer and more effective oral antifungal drugs.

Especially for patients who are resistant to the existing drug fluconazole, they urgently need new therapies to treat this disease.

Brexafemme is a new type of glucan synthase inhibitor, which combines the good activity of glucan synthase inhibitor with the potential flexibility of oral and intravenous administration, and is expected to be widely used in inpatient and outpatient settings .

Currently, the drug is being developed to treat fungal infections mainly caused by Candida and Aspergillus.

In in vitro and in vivo studies, it has shown broad-spectrum antifungal activity.

Previously, the US FDA had granted Brexafemme Qualified Infectious Disease Product (QIDP), Fast Track, and Orphan Drug Designation.

▲Brief introduction of Brexafemme (ibrexafungerp) (picture source: Scynexis official website) "The approval of Brexafemme by the US FDA is the culmination of our many years of work and an important milestone for Scinexis.

We are very pleased to be able to provide one for women suffering from vaginal yeast infections.
New treatment options.

" said Dr.
Marco Taglietti, President and CEO of Scynexis. Reference: [1] SCYNEXIS Announces FDA Approval of BREXAFEMME® (ibrexafungerp tablets) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections.
Retrieved June 2, 2021, from https:// -release/2021/06/02/2240294/0/en/SCYNEXIS-Announces-FDA-Approval-of-BREXAFEMME-ibrexafungerp-tablets-as-the-First-and-Only-Oral-Non-Azole-Treatment-for -Vaginal-Yeast-Infections.
html Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.

If you need guidance on the treatment plan, please go to a regular hospital for treatment.