My Husband Became a Poster Child of the Post-Antibiotic Era

Re:My Husband Became a Poster Child of the Post-Antibiotic Era by sithadmin on Saturday May 04, 2019 @06:00PM (#19829657)

Extremely scared, especially in light of barriers to drug approval killing off interest in antibiotics development. Just take a look at what happened to Achaogen: http://www.bioworld.com/perspectives/2019/04/24/a-decade-of-...

The FDA granted Fast Track designation for their antibiotic, only later refuse to approve it for use in bloodstream infections due to quibbling over study size (which was admittedly smaller than it could have been, largely in part due to the Fast Track designation). The antibiotic has been relegated to on-label use for complicated UTIs. Though it can still be used off-label, this isn't enough to attract further investment or keep sales strong enough to sustain ongoing operations. Achaogen was forced to lay off nearly all staff, and is now entering bankruptcy.

Unfortunately, this sort of thing is hardly unique among early stage pharma companies focusing on antibiotics, and it's steering investors away from such companies. It's also driving pharma professionals away.

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Re:My Husband Became a Poster Child of the Post-Antibiotic Era by pkaye on Sunday May 05, 2019 @12:20AM (#19831135)

But they could still get approval in other countries.

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Re:My Husband Became a Poster Child of the Post-Antibiotic Era by BurningFrog on Sunday May 05, 2019 @01:15AM (#19831298)

As I understand it, other countries are not very profitable as pharmaceutical markets, so they probably won't get developed in the first place there.

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Re:My Husband Became a Poster Child of the Post-Antibiotic Era by sithadmin on Sunday May 05, 2019 @12:46AM (#19831223)

Wouldn't have mattered previously, won't matter going forward. The USA is the most important and lucrative market, whether we like it or not.

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