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Pfizer has announced that the U.S. FDA has approved a new drug application for Eucrisa ,2 percent ointment, allowing the drug to be used in the treatment of mild to moderate-specific dermatitis in 3 to 24-month-old children.
Eucrisa is a nonsteroidal PDE4 inhibitor that mediates the conversion of cyclophosphate adenosine (cAMP) to adenosine monophosphate (AMP), thereby reducing intracellular cAMP levels.
the drug was originally developed by Anacor, a US biopharmaceutical company, which Pfizer bought in December 2016 in $5.2 billion in cash, and Eucrisa, the central asset of the deal, was bought by Pfizer.
in the United States, Eucrisa was approved for use in children 2 years and older with mild to moderate specific dermatitis in children and adults.
In addition to the United States, the drug has also been approved in Canada, Australia and Israel.
-specific dermatitis is a special type of eczema, is a serious chronic inflammatory skin disease, mainly manifested in severe itching, obvious eczema-like change and dry skin.
in the United States, teriolyderitis affects nearly 18 million adults and about 11 percent of children.
, about 10% of adults and 20% of children worldwide are affected by adhesion altrate, of which 45% occur six months ago, 60% before the age of one, 85% before the age of 5, and about 50% of children experience recurrent episodes in adolescence and adulthood. as a result, there is a significant unmet medical need for innovative therapies in this area,
.
Although adhelilate dermatitis usually begins in infancy, there are currently limited options for approved treatment for the patient's population.
Pfizer said the expanded approval makes Eucrisa the first hormone-free local lysis for children with mild to moderate dermatitis at 3 months.
approval is based on data from an open label IV clinical study that assessed the safety and effectiveness of eucrisa use in children between 3 months and 24 months of age with mild to moderate specific dermatitis.
in the study, Eucrisa was well tolerated, its efficacy validated, and no new safety issues were identified.
in China, Eucrisa uses the disease as a chronic recurrent inflammatory skin disease with limited treatment methods that provide an effective drug option for patients who are not tolerated or ineffective in existing therapies.
" was included in the second batch of clinically urgently needed new drugs. On February 10,
, Pfizer's application for a listing in China was accepted by CDE.
Reference source: Pfizer Pediatric Wins New Approval for Atopic Dermatitis Ointment Eucrisa.