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    Home > Active Ingredient News > Immunology News > Spots or medicine available! CTP-543 Obtains FDA Breakthrough Therapy Recognition

    Spots or medicine available! CTP-543 Obtains FDA Breakthrough Therapy Recognition

    • Last Update: 2020-07-14
    • Source: Internet
    • Author: User
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    The Pharmaceutical Company concert recently announced that the U.SFood and Drug AdministrationAdministration(
    FDA) has awarded oral Janus kinase inhibitor CTP-543 breakthrough therapy for the treatment of moderate to severe adult baldnessThere is currently no FDA-approved treatment for baldness, an auto
    immunedisease in which the patient's immune system attacks the hair follicles, leading to baldness or complete hair lossDr Roger Tung, President and CEO of Concert Pharmaceuticals, said, "We are pleased that the FDA recognizes the potential of CTP-543 as a treatment for baldnessOur goal is to bring this potential treatment to patients as soon as possibleWe look forward to working closely with the FDA to accelerate the development of CTP-543."this approval is supported by Phase II clinical trialsIn September 2019, Concert reported that patients who received 8mg CTP-543 twice a day or 12mg CTP-543 twice a day reached the primary endpoint, and that the severity of hair loss (SALT) in patients in the CTP-543 treatment group was significantly lower than in the placebo group (p.001), and that at 24 weeks, THE CTP-543 patients had a change of 50 percent of the baseline in the CTP-543 treatment groupThe patient was well tolerated with CTP-543 and reported a severe adverse event in the 12 mg dose group, but the patient was able to complete the trial after a brief interruption of treatment
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