A woman in Nevada died from an infection that counterattacked every kind of antibiotic in US, Nevada. The incident, which the CDC reported Thursday, is part of the growing problem of antibiotic immunity, which is on theory could kill 10 million people by 2050.
Why Is It So Hard To Get New Antibiotics Approved?
"I think it's in a point of. We have depended on for so long on just newer and newer antibiotics. But obviously the bugs can often grow resistance quicker than we can make new ones," Alexander Kallen, a medical officer at the Center for Disease Control and Prevention's division of health care quality elevation told Stat News.
As an unlucky result, many major pharmaceutical companies have stopped developing new antibiotics overall. Last year for example, the FDA turned down Cempra Pharmaceuticals' new antibiotic, a drug intended to fight a type of bacterial pneumonia called solithromycin, mentioning too little information on how the drug might affect the liver.
Omadacycline By Paratek Pharmaceuticals To Take Down Resistant Superbug
Despite these barricades, biotech company Paratek Pharmaceuticals is currently at work on a new antibiotic called omadacycline. So far, the approval progression for the drug has taken roughly two decades now.
The drug would treat skin taints, pneumonia, and urinary tract infections, and the company expects results from phase 3 trials observing at skin infections and pneumonia by July 2017. "After 21 years of investment ... we will have the essential data," Paratek President Evan Loh told Business Insider at the JPMorgan healthcare session on Thursday.
From the time the drug went into human trials to when it could hypothetically get on the market, 15 years will have passed, he said. So why it does take so long? Part of the problem is just science: sorting through different complexes to figure out what antibiotic might work can take period. But it also has a lot to do with the firms running the trials staying afloat monetarily, said Loh. And at that point, sometimes lawmaking can come in handy.
Loh said the GAIN Act helped Paratek "save the company" by expanding Paratek's patents on its antibiotic by five years. The act, which passed in 2012, aimed to incentivize companies to develop antibiotics by giving them extra time under patent safety to make money before facing generic race. If permitted, Paratek's new drug could be added to the collection of medicines intended to take on resistant bacteria, which will be key as more deaths ascribed to antibiotic-resistant bacteria occur.
"In the pre-antibiotic era, people were dead by the time they were 30 because of contaminations. Can you ever imagine that a situation where we get back to that condition?" Paratek Chief Commercial Officer Adam Woodrow asked Business Insider. "There was once this time where we were keeping up. Now we've sort of fallen in arrears," said Woodrow. "And the group of antibiotics that should be there to fight these pathogens have just vanished."