FDA approves new label for sarecycline

June 29, 2020

Almirall announces the U.S. Food and Drug Administration has approved the updated label for their oral antibiotic sarecycline (Seysara) for treatment of acne vulgaris to help promote the appropriate use of the drug to aid in preventing antimicrobial resistance commonly warned when using antibiotics

The U.S. Food and Drug Administration (FDA) has recently approved the new label for sarecycline (Seysara, Almirall), which contains an update to the Microbiology Section of the prescribing information that states P. acnes strains displayed a low propensity for developing resistance to the drug.1

Sarecycline, an oral tetracycline-based antibiotic, was initially approved by the FDA in October 2018 to treat non-nodular moderate-to-severe acne vulgaris in patients 9 years and older.2 The drug was launched in January 2019 and has since been prescribed to over 100,000 patients, according to a company press release.1

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“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,” says Ayman Grada, M.D., head of R&D and Medical Affairs for Almirall U.S.

Recent American Academy of Dermatology (AAD) guidelines suggest oral antibiotics as a first-line treatment for moderate-to-severe acne vulgaris; however, the Almirall announcement states sarecycline is the only oral antibiotic explicitly created and studied to treat this particular indication.

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However, there have been mounting concerns for using antibiotics to treat acne, and with the Centers for Disease Control and Prevention (CDC) stressing the importance of antibiotic stewardship due to concerns about antimicrobial resistance, some physicians are opting to avoid them.

With this label update, Almirall is aiming 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,” according to the press release.1 "We support antibiotic stewardship and the appropriate use of antibiotics in general, including when used to treat dermatologic conditions,” Dr. Grada adds.

Ron Menezes, president and general manager at Almirall, LLC, says, "We are delighted that the FDA recognized the importance of this data and approved the update to our label. This highlights Seysara as a distinct option for the treatment of the appropriate acne patient."

References:

1. BioSpace. (2020, June 18). Almirall Announces FDA Approval Of Updated Label For Seysara® (Sarecycline) Tablets. Retrieved June 30, 2020, from https://www.biospace.com/article/releases/almirall-announces-fda-approval-of-updated-label-for-seysara-sarecycline-tablets/

2. D. (2018, November 13). Sarecycline approved for moderate-to-severe acne. Retrieved June 30, 2020, from https://www.dermatologytimes.com/view/sarecycline-approved-moderate-severe-acne