Label Update: Low Risk of Antibiotic Resistance with Almirall's Seysara
The FDA approved a label change stating that P. acnes strains displayed a low propensity for the development of resistance to sarecycline.
The FDA approved a label update for Almirall's Seysara stating that P. acnes strains displayed a low propensity for the development of resistance to sarecycline.
This information is included in the Microbiology Section (12.4) of the prescribing information.
Seysara is a novel tetracycline-derived oral antibiotic developed specifically for the treatment of acne, and was approved by the FDA in October 2018. Since its launch in January 2019, Seysara has been prescribed for close to 100,000 patients.
"The data demonstrated that P. acnes strains display low propensity for the development of resistance to sarecycline, with spontaneous mutation frequencies being 10-10 (or 1 in 10 billion) at 4 to 8 times the minimum inhibitory concentration (MIC). What this means in practice is that the main bacterium associated with acne (P acnes) has shown very low potential of developing resistance to sarecycline," states Ayman Grada, MD, Head of R&D and Medical Affairs for Almirall US, in a news release.
Oral antibiotics are a first-line treatment for moderate to severe acne, according to the most recent American Academy of Dermatology (AAD) guidelines on the management of acne. However Seysara is the only one specifically designed and studied for this indication.
Due to concerns regarding antimicrobial resistance, the Centers for Disease Control and Prevention (CDC) has stressed antibiotic stewardship. This is an initiative to promote the appropriate use of antibiotics where patients receive the right dose of the right antibiotic at the right time for the right duration.
Dr. Grada adds, "We support antibiotic stewardship and the appropriate use of antibiotics in general, including when used to treat dermatologic conditions."
"When considering the importance of antibiotic stewardship, this new data for sarecycline provides another reason to consider it as a viable treatment option for inflammatory lesions of non-nodular moderate to severe acne," says Dr. Lawrence Eichenfield, Professor of Dermatology and Pediatrics at the University of California, San Diego and Rady Children's Hospital, San Diego.