Johnson & Johnson Seeks FDA OK of Spravato as Monotherapy

Dow Jones07-22

By Colin Kellaher

Johnson & Johnson is seeking Food and Drug Administration expanded approval of its Spravato nasal spray as a lone therapy for adults with treatment-resistant depression.

Johnson & Johnson on Monday said its application to the FDA is backed by data from a Phase 4 study in which Spravato as monotherapy showed rapid improvement in depressive symptoms at 24 hours that was sustained through at least four weeks.

The New Brunswick, N.J., healthcare giant said an FDA green light would make Spravato the first and only monotherapy for adults with treatment-resistant depression, meaning they have been unable to find relief from at least two treatments.

The FDA in 2019 approved Spravato, a close chemical relation to ketamine, in combination with an oral antidepressant, for adults with treatment-resistant depression.

Spravato generated full-year sales of $689 million in 2023, up 84% from $374 million the year before.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

July 22, 2024 08:45 ET (12:45 GMT)

Copyright (c) 2024 Dow Jones & Company, Inc.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2453980762?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2024-07-22 20:45","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2453980762","market":"sh","top_or_hot":-1,"title":"Johnson & Johnson Seeks FDA OK of Spravato as Monotherapy","media":"Dow Jones","content":"<font class=\"NormalMinus1\" face=\"Arial\">\n<pre>\n \n</pre>\n<p>\n  By Colin Kellaher \n</p>\n<pre>\n \n</pre>\n<p>\n  Johnson &amp; Johnson is seeking Food and Drug Administration expanded approval of its Spravato nasal spray as a lone therapy for adults with treatment-resistant depression. \n</p>\n<p>\n  Johnson &amp; Johnson on Monday said its application to the FDA is backed by data from a Phase 4 study in which Spravato as monotherapy showed rapid improvement in depressive symptoms at 24 hours that was sustained through at least four weeks. \n</p>\n<p>\n  The New Brunswick, N.J., healthcare giant said an FDA green light would make Spravato the first and only monotherapy for adults with treatment-resistant depression, meaning they have been unable to find relief from at least two treatments. \n</p>\n<p>\n  The FDA in 2019 approved Spravato, a close chemical relation to ketamine, in combination with an oral antidepressant, for adults with treatment-resistant depression. \n</p>\n<p>\n  Spravato generated full-year sales of $689 million in 2023, up 84% from $374 million the year before. \n</p>\n<pre>\n \n</pre>\n<p>\n  Write to Colin Kellaher at colin.kellaher@wsj.com \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  July 22, 2024 08:45 ET (12:45 GMT)\n</p>\n<p>\n  Copyright (c) 2024 Dow Jones &amp; Company, Inc.\n</p>\n</font>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Johnson & Johnson Seeks FDA OK of Spravato as Monotherapy</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nJohnson & Johnson Seeks FDA OK of Spravato as Monotherapy\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-07-22 20:45 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://dowjonesnews.com/newdjn/logon.aspx?AL=N><strong>Dow Jones</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>By Colin Kellaher \n\n\n \n\n\n  Johnson & Johnson is seeking Food and Drug Administration expanded approval of its Spravato nasal spray as a lone therapy for adults with treatment-resistant depression. \n\n\n...</p>\n\n<a href=\"https://dowjonesnews.com/newdjn/logon.aspx?AL=N\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4559","symbol_name":"巴菲特持仓","start_time":0,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","article_id":"2453980762","we_media_id":"106","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2453980762","pubTimestamp":1721652300,"sourceInfo":null,"weMediaInfo":{"media_name":"Dow Jones","introduction":"Dow Jones publishes the world’s most trusted business news and financial information in a variety of media.","home_visible":0,"id":"106","head_image":"https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99"},"summary":"Johnson & Johnson is seeking Food and Drug Administration expanded approval of its Spravato nasal spray as a lone therapy for adults with treatment-resistant depression.Johnson & Johnson on Monday said its application to the FDA is backed by data from a Phase 4 study in which Spravato as monotherapy showed rapid improvement in depressive symptoms at 24 hours that was sustained through at least four weeks.The New Brunswick, N.J., healthcare giant said an FDA green light would make Spravato the first and only monotherapy for adults with treatment-resistant depression, meaning they have been unable to find relief from at least two treatments.The FDA in 2019 approved Spravato, a close chemical relation to ketamine, in combination with an oral antidepressant, for adults with treatment-resistant depression.Spravato generated full-year sales of $689 million in 2023, up 84% from $374 million the year before.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4559":"巴菲特持仓","IE0034235303.USD":"PINEBRIDGE US RESEARCH ENHANCED CORE EQUITY \"A\" (USD) ACC","LU2133065610.SGD":"JPMorgan Investment Funds - Global Dividend A (mth) SGD","SG9999001440.SGD":"United Global Dividend Equity Fund A SGD Dist","LU2468319806.SGD":"MANULIFE GF HEALTHCARE \"AA\" (SGDHDG) ACC","LU2602419157.SGD":"HSBC ISLAMIC GLOBAL EQUITY INDEX \"AC\" (SGD) ACC","BK4588":"碎股","BK4550":"红杉资本持仓","LU0345770993.USD":"NINETY ONE GSF GLOBAL STRATEGIC EQUITY \"A\" (USD) INC","LU1585245621.USD":"EASTSPRING INV GLOBAL LOW VOLATILITY EQUITY FUND \"A\" (USD) ACC B","LU0795875086.SGD":"JPMorgan Investment Funds - Global Income A (div) SGD","LU1244550494.USD":"FRANKLIN GLOBAL MULTI-ASSET INCOME \"A\" (USDHEDGED) ACC","IE00B7SZLL34.SGD":"Legg Mason ClearBridge - Value A Acc SGD-H","LU1929549753.HKD":"FRANKLIN INCOME \"A\" (HKD) INC","LU0889566641.SGD":"FTSF - Templeton Shariah Global Equity A Acc SGD","LU1032955483.USD":"NORDEA 1 STABLE RETURN \"HB\" (USDHDG) ACC","LU1280957306.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQUITIES \"AUP\" (USD) INC","LU0792757196.USD":"TEMPLETON SHARIAH GLOBAL EQUITY FUND \"A\" (USD) ACC","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","LU1261432733.SGD":"Fidelity World A-ACC-SGD","LU1066051811.HKD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (HKD) INC","LU1732800096.USD":"摩根大通环球收益基金A (irc)","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","LU1162221912.USD":"FRANKLIN INCOME \"A\" (USD) ACC","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","LU0640476718.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQ \"AU\" (USD) ACC","LU0912757837.SGD":"JPMorgan Investment Funds - Global Income A (mth) SGD-H","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","LU1221951046.USD":"NORDEA 1 STABLE RETURN \"HM\" (USDHDG) INC","LU0234572021.USD":"高盛美国核心股票组合Acc","LU0320765646.SGD":"FTIF - Franklin Income A MDIS SGD-H1","LU1221951129.SGD":"NORDEA 1 STABLE RETURN \"HM\" (SGDHDG) INC","BK4532":"文艺复兴科技持仓","SG9999002224.SGD":"Allianz Global High Payout SGD","BK4592":"伊斯兰概念","LU1267930813.SGD":"FRANKLIN TEMPLETON SHARIAH GLOBAL EQUITY \"AS\" (SGD) ACC","JNJ":"强生","LU2347655156.SGD":"JPMorgan Investment Funds - Global Income A (icdiv) SGD-H","LU0345770308.USD":"NINETY ONE GSF GLOBAL STRATEGIC EQUITY \"A\" (USD) ACC","BK4534":"瑞士信贷持仓","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","LU1430594728.SGD":"Eastspring Investments - Global Low Volatility Equity AS SGD","LU1196500208.SGD":"NORDEA STABLE RETURN \"HB\" (SGDHDG) ACC","LU1032466523.USD":"高盛全球多资产收益组合Acc","LU1059921491.USD":"NORDEA 1 GLOBAL STABLE EQUITY \"HB\" (USDHDG) ACC","IE00B1BXHZ80.USD":"Legg Mason ClearBridge - US Appreciation A Acc USD","LU0122379950.USD":"贝莱德世界健康科学A2","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","LU1244550577.SGD":"FTIF - Franklin Global Multi-Asset Income A (Mdis) SGD-H1"},"translate_title":"强生公司寻求FDA批准Spravato作为单一疗法","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"JNJ":1},"content_text":"By Colin Kellaher \n\n\n \n\n\n  Johnson & Johnson is seeking Food and Drug Administration expanded approval of its Spravato nasal spray as a lone therapy for adults with treatment-resistant depression. \n\n\n  Johnson & Johnson on Monday said its application to the FDA is backed by data from a Phase 4 study in which Spravato as monotherapy showed rapid improvement in depressive symptoms at 24 hours that was sustained through at least four weeks. \n\n\n  The New Brunswick, N.J., healthcare giant said an FDA green light would make Spravato the first and only monotherapy for adults with treatment-resistant depression, meaning they have been unable to find relief from at least two treatments. \n\n\n  The FDA in 2019 approved Spravato, a close chemical relation to ketamine, in combination with an oral antidepressant, for adults with treatment-resistant depression. \n\n\n  Spravato generated full-year sales of $689 million in 2023, up 84% from $374 million the year before. \n\n\n \n\n\n  Write to Colin Kellaher at colin.kellaher@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  July 22, 2024 08:45 ET (12:45 GMT)\n\n\n  Copyright (c) 2024 Dow Jones & Company, Inc.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"Policy And Regulatory","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.0","shortVersion":"4.29.0","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2453980762"}