Sage Therapeutics Zulresso treatment of PPD has good risk benefits
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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PPD is a clear and easily identifiable form of severe depression, a common birth complication that affects some pregnant women and usually occurs late in pregnancy or within 4 weeks of childbirthrecently, Sage Therapeutics(announced that theAdvisory(PDAC) and the Advisory Committee on Drug Safety and Risk Management (PDARM) of the Food andMedicines(
) had held ameeting totheof new drugs for the companyThe (brexanolone) injection for the treatment of postpartum depression (PPD) of the new drug application (NDA) was reviewed and voted jointly, and by 17 votes in favor, 1 vote against the results, the results of the NDA included in the efficacy and safety data support the Zulresso treatment of PPD has a good riskIt's worth noting that Zulresso is the first drug under FDA review that specializes in treating PPDThe FDA usually adopts its committee's recommendations when it makes a final review decisionThis also means that Zulresso is likely to get FDA approvalIf approved, SAGE-547 would be the first drug specifically designed to treat PPD, changing the clinical treatment model for PPDabout brexanolone brexanolone is a morphomorphic regulator that acts on both synaptic and synaptic GABAA receptors The variable regulation of neurotransmitter receptor activity can produce various degrees of desired activity, rather than full activation or total inhibition currently, Sage is developing its proprietary intravenous formulation, brexanolone, for PPD treatment in the United States, the FDA has granted brexanolone a breakthrough drug qualification (BTD) for the treatment of PPD, and in the European Union, the EMA has also granted priority drug eligibility (PRIME)
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