FDA approves new base Otezla for adult patients to treat mouth ulcers associated with white congestion disease

recently, TheAdministration of food anddrugs http://
(http://has approved Otezla (apremilast) 30mg twice a day (BID) for adult patients to treat mouth ulcers associated with behet's disease (Bhcet's disease, BD)About Otezla
Otezla is an oral, selective diesterase 4 (PDE4) inhibitor that is the first and only drug to receive regulatory approval for the treatment of BD-related mouth ulcersApplications for new indications for Otezla's treatment of mouth ulcers related to white sesame disease are also under review in Japan and the European UnionJapan expects to receive the results of the review in the second half of 2019In the United States, Otezla is now approved for three types of anindications, including:(1) for patients with moderate to severe plaque-type psoriasis for phototherapy or systemic treatment,(2) adult patients with active psoriasis arthritis, and(3) adult patients with mouth ulcers associated with white congestion diseaseSince the FDA's first approval in 2014, Otezla has prescribed more than 250,000 patients in the United States with moderate to severe plaque-type psoriasis or active psoriasis arthritisThe study FDA-approved Otezla's treatment of caucasian-related oral ulcers, based on the efficacy and safety results of the randomized, placebo-controlled, double-blind Phase III RELIEF study 　　The study enrolled 207 adult patients with pericardial ulcers who had received at least one abiotic drug and were suitable for systematic treatment The study assessed Otezla's efficacy and safety relative to placebo 　　The results showed that the Otezla 30mg twice-daily (BID) treatment group had 42.7 points lower in oral ulcer pain than baseline and the placebo group 18.7 points lower than baseline sashimi in the 12th week, as measured by the Visual Simulation Scale (VAS) The proportion of patients who achieved complete remission of oral ulcers (no oral ulcers) at week 12 was 52.9% in the Otezla treatment group and 22.3% in the placebo group The proportion of patients who reached complete remission of oral ulcers at week 6 and remained without ulcers for the remaining 6 weeks of treatment at 12 weeks was 29.8 percent in the Otezla treatment group and 4.9 percent in the placebo group 　　During the 12-week treatment period, the average daily oral ulcer count in the Otezla treatment group and the placebo group was 1.5 and 2.6, respectively (based on baseline and 1, 2, 4, 6, 8, 10 and 12 weeks of oral ulcer count) 　　In the safety study, the most common adverse events observed were diarrhea (Otezla 41.3%, placebo group 20.4%), nausea (Otezla group 19.2%, placebo group 10.7%), headache (Otezla group 14.4%, placebo group 10.7%), upper respiratory tract infection (Otezla group 11.5% and placebo group 4.9%) Otezla's safety characteristics are consistent with those known to the drug