FDA approves Seysara for moderate to severe acne

The US Food and Drug Administration (FDA) has approved Seysara(sarecycline), a new, first in class tetracycline-derived oral antibiotic for inflammatory lesions associated with non-nodular moderate to severe acne vulgaris in patients nine years of age and older. Seysara was part of Allergan’s Medical Dermatology portfolio, recently acquired by Almirall for the United States. It is expected to be launched in January 2019. 

Seysara is 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 the treatment and is generally safe and well tolerated. Seysara represents an innovative treatment for patients with moderate to severe acne. 

Peter Guenter, Chief Executive Officer, Almirall, commented “We are proud to have obtained the FDA’s approval for Seysara, which will bring a new option for the many patients with unmet medical needs. It brings a major launch opportunity for Almirall in the US of an innovative first-in-class treatment for moderate to severe acne. This constitutes an important milestone for our medical dermatology portfolio in the US market, the biggest dermatology market in the world. We expect Seysara to reach peak sales of $150 MM  to $200 MM.”

Dr Leon Kircik, a leading US dermatologist from Louisville, Kentucky and a sarecycline clinical trialist, added “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.”