FDA backs updated label for Seysara

The US subsidiary of Spain’s largest drugmaker Almirall (ALM: MC) today announced that the US Food and Drug Administration has approved an important update to the Seysara (sarecycline) label stating that P. acne 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, said Almirall.

"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," stated Dr Ayman Grada, head of R&D and medical affairs for Almirall US.