New anti-inflammatory drugs! Sanofi/Regenerative Dollar Dupixent (Dabito ®) 300mg single-dose prefilled pen approved by the U.S. FDA!
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Last Update: 2020-07-20
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Source: Internet
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Author: User
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, June 24, 2020 //BiovalleyBIOON/Sanofi and Regeneron recently jointly announced that the U.SFood and Drug Administration (
FDA) has approved Dupixent (Dabitto ®, generic name: Duplyumonotag, dupiupiab) 300mg single-dose pre-injected penThis pre-filled pen is approved for all approved indications in the population of patients aged 12 years, including certain adhesionderitis,asthma, chronic nasal sinusitis associated with nasal polyps (CRSwNP) patients, and is administered at homeThe new pre-filled pen will provide patients with a more convenient treatment optionit is worth noting that just last week, Dupixent (Dabito ®) was approved by the State Drug Administration (NMPA) to treat moderate to severe adhesionitis (AD) in adultsDabito ® is the world's first and only approved treatment of adults of moderate to severe adhesion dermatitis targeted biological agents, to fill the domestic clinical lysactime unmet needs, can quickly, significantly, and continuously improve the degree of epithelial skin damage and itching symptoms of patients with aspecific dermatitisThanks to the drug regulatory reform, The ® was approved in China two years ahead of schedule, providing chinese patients with a new treatment optionDrGeorge DYancopoulos, co-founder, president and chief scientific officer ofRegeneration, said: "Chronic inflammatory diseases such as adhesilial dermatitis, asthma and chronic nasal sinusitis with nasal polyps are extremely complex lysate and make patients feel burdened and worried about their treatment options Dupixent prefilled injection pens specifically provide patients with an easy-to-use and convenient option so they can be treated more comfortably "
Dupixent 300mg pre-filled pen is expected to be available in the United States in the third quarter of 2020 This pre-filled injection pen features hidden needles and single-click auto-injection, as well as visual and audio feedback to help administer the drug Regenerative Dollar and Sanofi are working with the FDA to provide additional data for the agency to complete the 200mg pre-charged pen review Pre-filled syringes will continue to be sold at 200 mg and 300 mg for use by clinics or families Both methods of administration require training of medical professionals "We know that injections or injections, especially for patients who need regular medications, can be daunting for patients or their parents or caregivers," said Bill Sibold, executive vice president and head of Genzyme, a Sanofi Dupixent pre-filled injection pens use the latest technology, including visual and audio cues, to help support the drug when injected "
a key driver of Dupixent's targeted type 2 inflammation, an all-humanized monoclonal antibody that specifically inhibits the overactivation signals of two key proteins, IL-4 and IL-13 IL-4/IL-13 is two inflammatory factors that are thought to be key drivers of internal inflammation in allergic diseases and other type 2 inflammatory diseases, including epithelial dermatitis, asthma , acidosis cell esophagitis, grass allergy, peanut allergy, etc Dupixent was listed at the end of March 2017 as the world's first biological agent for the treatment of moderate-to-severe aspecific dermatitis To date, the drug has been approved by many countries and regions, including the United States, the European Union and Japan In the United States, Dupixent is now approved for treatment of three diseases caused by type 2 inflammation: moderate to severe aditary dermatitis (in patients aged 6), moderate to severe asthma (in patients with 12 years of age), and chronic sinusitis (CRSwNP, adult sinus) currently, Sanofi and Regenerative Element are also conducting an extensive clinical project to assess Dupixent's treatment of diseases caused by allergies and other type 2 inflammations, including: asthma in children (6-11 years, Phase III), specialder dermatitis in children (6 months to 5 years, II /III), eosinophilic esophagitis (Stage III), chronic obstructive pulmonary disease (Stage III), large herpes (Phase III), nodule itch rash (Phase III), chronic spontaneous urticaria (Stage III), food and environmental allergies (Phase II) Dupixent is another important product that Sanofi has developed in collaboration with The Regenerative Santil, a consumer-reducing drug, and is expected to become a game-changer Dupixent's indications are steadily increasing, with Evaluate Pharma, a leading pharmaceutical market research firm, predicting global sales could reach $8 billion in 2024 (biovalleybioon.com) original source: FDA
app, new ® (dupilumab) Pre-filled Pen Designed to Support More Convenient Little Self-Administration .
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