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FDA approves Seysara for moderate to severe acne
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Today, the FDA approved Seysara to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients aged 9 years and older, according to a press release issued by the drug manufacturer.
Seysara (sarecycline, Almirall) is a new first in class tetracycline-derived oral antibiotic that should be taken once daily with or without food, according to the release.
The approval was based on two 12-week multicenter, randomized, double-blind, placebo-controlled studies including 2,002 patients. In the trials, sarecycline proved to significantly reduce the severity of inflammatory lesions as early as three weeks after the initiation of treatment, according to the release.
Sarecycline is expected to launch in January 2019, according to the release.
“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,” Peter Guenter, CEO of Almirall, said in the release.
The oral tablet also demonstrated safety and tolerability, according to the release.
“As dermatologists we are always seeking ways to improve the management of our patients’ disease,” Leon Kircik, MD, dermatologist from Louisville, Kentucky and a clinical trialist, said in the release. “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.”
Disclosure: Healio Internal Medicine was unable to confirm relevant financial disclosures at the time of publication.