New drug for special dermatitis! Otsuka outside the PDE4 inhibitor defamilast applied for listing, Pfizer similar products Shutanming has been listed in China!

September 30, 2020 // -- Otsuka recently announced that it has submitted a new drug application (NDA) for the treatment of patients with defamilast (OPA-15406) to the Japan Medicines and Medical Devices Administration (PMDA).
(AD) is a chronic inflammatory skin disease characterized by redness and rupture of the skin, accompanied by severe itching.
the disease is most common in infants and young children aged 3-6 months, with about 60 per cent of patients developing the disease within the first year of life and 90 per cent before the age of 5.
most patients disappear in childhood, but 10 to 30 percent of patients have a lifelong illness.
in Japan, there are about 4.34 million patients with special dermatitis, and this number is increasing year by year.
specialty dermatitis (Photo: diseaseslab.com) difamilast is a candidate drug for external endotent dermatitis found in Otsuka, a nonsteroidal, locally anti-inflammatory disterase 4 (PDE4) inhibitor that is currently being developed for the treatment of mild to moderate AD.
the drug has PDE4 inhibitory activity and is thought to play an anti-inflammatory role by inhibiting the production of inflammatory cytokines and chemical media, which are thought to cause AD symptoms and signs.
defamilast has a highly selective inhibitory activity on the B subtype of PDE4, an enzyme that plays an important role in inflammation.
March of this year, Otsuka Pharmaceuticals published the top-line results of two Phase III clinical trials of the defamilast treatment for mild to moderate endexual dermatitis (AD): one in adults and the other in children, in which the defamilast ointment was applied twice a day for four weeks.
the main endpoint of the study was defined as the proportion of patients with an overall assessment (IGA) score of 0 (complete removal of skin loss) or 1 (almost complete removal) and an improvement of at least 2 points relative to the baseline level.
results showed that both trials reached the main endpoint: the IGA success rate of difamilast treatment group was higher and the difference was statistically significant.
trial, the difamilast treatment group did not find significant adverse events.
currently, Pfizer is also selling Eucrisa (Chinese, a nonsteroidal PDE4 inhibitor-type AD drug with a generic name: crisaborole, creborole, 2% ointment, approved for sale in December 2016 for the treatment of mild to moderate specialty dermatitis (AD) in children and adults aged ≥2 years.
March, Eucrisa was approved by the FDA to treat infants and young children ≥3 months of age, becoming the first and only locally prescribed steroid-free drug for pediatric patients as young as 3 months of mild to moderate AD.
In China, Eucrisa (Shutanming, Kryboro, 2% ointment) was approved at the end of July 2020 to become China's first non-hormonal external PDE4 inhibitor: the drug is used for topical treatment in patients 2 years of age and older with mild to moderate endopathic dermatitis (AD).
Thanks to NMPA-related policies, Shutanming entered China through a fast-track approval channel, and the approval of the drug marks an important milestone that will fill the unseeded treatment needs of Chinese children with endexual dermatitis, providing an opportunity to alleviate symptoms for the vast majority of Chinese patients with specific dermatitis, especially those aged 2 years and older.
In addition, in June this year, Sanofi biopharmaceutical Dabito ® (Dupixent®, generic name: Dupiu monoanti, dupilumab) was approved by the State Drug Administration to be listed in China for the treatment of moderate to severe endemic dermatitis (AD) in adults.
February, the China Guidelines for the Treatment of Specific Dermatitis (2020) issued a recommendation to include the yet-to-be-listed dabito ® in the hope that the new drug would fill the unsuperfilled demand for the current drug.
Dabito® is the world's first and only approved treatment of adult moderate to severe specific dermatitis targeted biological agents, filling the domestic clinical unsuperfected needs, can quickly, significantly and continuously improve the degree of skin damage and itching symptoms in patients with specific dermatitis.
the drug regulatory reform, Dabito was approved ® china two years in advance, providing New Treatment Options for Chinese patients.
Dabito® is an all-human monoclonal antibody, through the "double target" innovative mechanism of action, selectively inhibit the key signaling pathline erythrin 4 (IL-4) and white melebin 13 (IL-13), block the type 2 inflammatory path, reduce the pathological response of type 2 inflammation, from the mechanism to treat type 2 inflammation-related diseases.
Dabito® was developed by Sanofi and Regeneratives and has so far been approved to treat three diseases caused by type 2 inflammation: moderate to severe endetic dermatitis (≥6 years of age), moderate to severe asthma (≥12 years of age), chronic nasal sinusitis (CRSwNP, adult patients).
() original source: Otsuka files Japan application for difamilast in atopic dermatitis.