By: IPP Bureau
Last updated : February 10, 2022 10:40 am
Adds five years of market exclusivity on approval
Evofem Biosciences announced that the U.S. Food and Drug Administration (FDA) has awarded "Qualified Infectious Disease Product" (QIDP) designation to EVO100 (the investigational name for Phexxi (lactic acid, citric acid and potassium bitartrate)) for the prevention of urogenital chlamydia infection in women, a potential new indication in late stage clinical development. Chlamydia is the most frequently reported bacterial infection in the United States.
Top-line data from EVOGUARD, the confirmatory Phase 3 trial of Phexxi for the prevention of chlamydia and gonorrhea, are expected in the third quarter of 2022. Positive outcomes could support submission to the FDA for these potential new indications in the first quarter of 2023.
"The unmet need for STI prevention for millions of women is significant when you consider that there are no FDA-approved products available to prevent infection with either chlamydia or gonorrhea," said Saundra Pelletier, CEO of Evofem Biosciences. "Every sexually active woman, no matter what form of contraception she is using, is potentially at risk to contract one of these STIs, which we believe represents a large potential new market opportunity for Evofem."
The CDC estimates that 4.0 million and 1.6 million new cases of chlamydia and gonorrhea, respectively, occurred in 2018 alone. The number of reported cases is lower than the estimated total number because infected people are often unaware of, and do not seek treatment for, their infections. Almost 60% of women infected with chlamydia have no symptoms.
Chlamydia and gonorrhea have been reported to be responsible for one-third to half of pelvic inflammatory disease (PID) cases. PID can cause serious, long-term problems including infertility, ectopic pregnancy, and chronic pelvic pain.
QIDP designation is intended to encourage development of new drugs for the treatment of serious or life-threatening infections. A drug or product in development that receives this designation qualifies for an additional five years of marketing exclusivity following FDA approval for that indication.