Seysara: Oral Antibiotic is First Approved for Dermatology in 40 Years

Tuesday, October 02, 2018 | FDA Approval/Clearance , Acne , Almirall


Seysara (sarecycline), a new, first in class tetracycline-derived oral antibiotic, is now approved for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Almirall, which recently acquired Seysara from Allergan, plans to launch the drug in January 2019.

Seysarais an oral tablet that is taken once daily with or without food. It has proven significant reduction of inflammatory lesions as early as three weeks after start of treatment and is generally safe and well tolerated. 

“As dermatologists we are always seeking ways to improve the management of our patients’ disease. The results of the studies are encouraging, with statistically significant efficacy vs placebo as early as 3 weeks. I’m looking forward to having this as an option for my patients when it becomes available in 2019,” says Leon Kircik, MD, who participated in clinical trials for Seysara.

With the approval of Seysara and its upcoming launch, Almirall says it will consolidate and reinforce its presence in the US, offering top dermatological products in the world's biggest market. Seysara is expected to reach peak sales of $150-200 Million.

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