{"id":3577,"date":"2025-06-02T22:16:45","date_gmt":"2025-06-03T04:16:45","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=3577"},"modified":"2025-08-21T18:52:37","modified_gmt":"2025-08-22T00:52:37","slug":"__trashed-2__trashed","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2025\/06\/02\/3577\/__trashed-2__trashed\/","title":{"rendered":"The 10 x \u201920 Initiative – A Retrospective"},"content":{"rendered":"\n
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It started all so well with fanfare and great expectations. Fifteen years ago, the 10 x \u201920 initiative got underway.<\/p>\n\n\n\n

Its goals were spelled out clearly: To \u2018Pursue a Global Commitment to Develop 10 New Antibacterial Drugs by 2020 \u2019[3]<\/a>.  It was driven by ID clinicians and by antibiotic developers concerned about a dry pipeline, rising resistance and industry abandoning anti-infective R&D [1]<\/a>.  They wanted to make the public aware of the situation and came up with a nice catchy phrase which still resonates today: \u201cBad Bugs, No Drugs\u201d, \u201cBad Bugs, No Drugs: no ESKAPE!\u201d [2]<\/a>. And a cool logo as well.<\/p>\n\n\n\n

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Looking back, we’d expect a publication from stakeholders taking stock and assessing achievements against plan. Amazingly, there is no report from IDSA or others touting 10 x ’20 achievements.  Why this silence? Was there really no progress? <\/p>\n\n\n\n

We compiled a table of all approvals between 2010 and 2019 (inclusive), together with our ratings of these newcomers.<\/p>\n\n\n\n

The Pew Trust website provides an elegant animated graphic showing antibiotics in development since 2014 [4]<\/a>; an earlier Annals article provides additional information on approvals between 2010 \u2013 2015 [5]<\/a>.  Together these 2 sources are the basis of our 10-year analysis and score card. <\/p>\n\n\n\n

A total of 18 new antibiotics received FDA approval in the last decade.  What at first glance looks like a respectable number, is less impressive on closer inspection. <\/strong> <\/p>\n\n\n\n

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As indicated in our color coding, most of these \u2018new\u2019 drugs are not really new, as most belong to established antibiotic classes, most being \u03b2-lactams.  In general \u2013 but not always \u2013 we get minor improvements in PK or in antimicrobial spectrum.<\/p>\n\n\n\n

But wait, not all is bleak.  There was real progress with at least some newcomers. The MVP title can be claimed by 2 drugs: cefiderocol\/FETROJA which adds an interesting new MoA (Fe channel) to its \u03b2-lactam profile, and lefamulin\/XENLETA, the long-awaited first pleuromutilin drug. Honorable mention goes to ceftazidime\/avibactam and ceftolozane\/tazobactam, both excellent drugs for CRE and P. aeruginosa, respectively. In the supporting category we have omadacycline, fidaxomicin and bedaquiline.  And vabomere, too, perhaps.<\/p>\n\n\n\n

How about the remainder of the 10 x \u201920 harvest?  It\u2019s slim pickings once you subtract all the me-too drugs.  Some long-acting glycopeptides came to market providing convenient once-weekly dosing, and a few drugs added MRSA coverage (delafloxacin, ceftaroline) at the expense of Gram-negative spectrum activity.  None of these me-too\u2019s saw much adoption in clinical practice.<\/p>\n\n\n\n

Speaking of the markets: they have not been kind to undifferentiated newcomers.  Indeed, 2 narrow-spectrum companies disappeared shortly after their drug was launched: <\/p>\n\n\n\n