BioPharma

FDA approves new triple-drug antibiotic from Merck

Recarbrio was approved for treating complex urinary tract and intra-abdominal infections among adult patients who have limited or no therapy options.

The Food and Drug Administration has approved a new antibiotic drug for patients with certain infections who have run out of options.

Kenilworth, New Jersey-based Merck & Co. said Wednesday that the FDA had approved Recarbrio (imipenem, cilastatin and relebactam), an injectable antibiotic for adult patients with complicated urinary tract infections, or cUTIs, and limited or no treatment options, as well as adults with certain complicated intra-abdominal infections, or cIAIs, and who also have limited or no treatment options. The company said the approval was based on limited clinical safety and efficacy data for cUTIs and cIAIs.

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Bacteria that cause the cUTIs and are treatable with Recarbrio include Gram-negative organisms like Enterobacter cloacea, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae and Pseudomonas aeruginosa. Susceptible bacteria that cause cIAI include all the aforementioned organisms, along with seven Bacteroides strains, Citrobacter freundii, Fusobacterium nucleatum, Klebsiella oxytoca and Parabacteroides distasonis.

The approval comes amid longstanding fears globally about antibiotic-resistant superbugs and talk of the possibility of a “post-antibiotic era.” A recent episode of the HBO near-future science fiction series “Years and Years,” for example, includes a subplot about a man dying from an antibiotic-resistant infection acquired when he falls and scrapes his hand.

However, the main barriers to developing new antibiotics to keep up with bacteria’s evolution are mostly economic rather than being a consequence of the limitations of science. As drugs that spend most of their lives on a pharmacy shelf and are only taken for a short period of time at relatively low cost, experts have said, antibiotics do not hold the same promise of becoming blockbusters as drugs to treat, say, cancers.

A case in point was the collapse of Achaogen, a once-promising firm developing antibiotics for drug-resistant infections that declared bankruptcy in April. However, other companies have soldiered on, including Qpex Biopharma, which launched with $33 million in Series A financing in October 2018 to develop new antibiotics. The company presented its first preclinical data on its product candidate last month.

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