From CNN Health reporters Rachel Uranga and Sarah-Jane Crawford:
The Food and Drug Administration has formally authorized a popular but controversial immunotherapy drug for use in emergency situations when a person has serious disease and has not responded to other medical treatments.
Five people have received injection-based immunotherapy (sometimes called a T-cell therapy or CAR-T) from AstraZeneca in a federal study since May. The drug, dalbavancin, is a fluoroquinolone that suppresses the immune system, and acts like a form of an anti-viral drug to create a temporary “blanket” over the body.
In these clinical trials, dalbavancin was given as a course of treatment after patients’ immune systems had recovered from a hard-to-treat bacterial infection. The trial did not test dalbavancin as a treatment for MRSA infections. As a result, there is no data available about dalbavancin’s effectiveness in fighting MRSA infections, since those patients tested negative for MRSA DNA.
But medical experts have been looking closely at dalbavancin in emergency cases because the drug holds promise as a potential way to treat dangerous MRSA infections.
Because the drug does not kill all bacteria, doctors decided to treat patients with lower doses, versus higher doses, of dalbavancin in the emergency setting, to give doctors additional knowledge about the drug. The drug is given as an infusion.
Dr. Michael Chan, chair of the Department of Medicine at Texas A&M University, who was not involved in dalbavancin’s safety studies, said that the new approval for emergency dalbavancin is a “game changer.”
“This is huge. It’s been anticipated for a long time,” he said.
The FDA went forward with dalbavancin’s approval because it had been studied in the emergency setting, and “significant clinical data demonstrated that dalbavancin can be used as an emergency immunotherapy without a clinical benefit being gained,” an FDA spokeswoman said in an email.
Dr. Paul Schmidt, chief of Infectious Diseases at Yale University, said, “This was the only treatment that worked,” in cases where dalbavancin can be safely used as an emergency drug.
Several other medicines have had a similar history. Tommie Tuoka, co-founder of Bridge Pathology, has been doing autopsies on MRSA patients for 17 years. He has seen how the drug helped control some MRSA infections.
“It’s a very effective treatment,” he said.
The biggest downside of dalbavancin is the side effects, such as mild to moderate nausea and diarrhea. Schmidt said doctors are trying to eliminate the side effects of dalbavancin in the emergency situation.
“They’re doing research to do more tailored treatment,” Schmidt said. “I haven’t seen this yet. I don’t know how it’s going to work.”
Even if dalbavancin can offer a treatment for MRSA infections, that’s not to say it is the right treatment for everyone. Schmidt said those tests should be done for other types of MRSA infections, and not for just MRSA.