FDA Approves New Treatments for Influenza and UTI

By Alfred Kristoffer A. Guiang | Dec 23, 2014 | 09:43 AM EST

With the continuing outbreak of influenza (flu) in 29 U.S states, and the recorded death of 11 children due to the disease, Americans should observe health practices for prevention from the disease. With tireless efforts of the government and pharmaceutical companies to find better cure, treatment and protection against contagious diseases and other diseases in general; new products are being produced and manufactured with the aim of improving the health and prolonging the life span of mankind.

Just recently another flu treatment got the approval of the Food and Drug Administration (FDA). For flu patients who are unable to take medication orally or by inhalation, the intravenous flu treatment Peramivir manufactured by BioCryst Pharmaceuticals finally got the nod from the FDA.

Peramivir, which was developed under a $235-million contract with the federal government, is the first flu IV antiviral approved in the U.S in 15 years, and is said to deliver high plasma doses to infected areas. BioCryst has said peramivir is effective against multiple flu strains, including the H1N1 swine flu.

The drug is a neuraminidase inhibitor, like oseltamivir (Tamiflu) and zanamivir (Relenza), but given as a single-dose IV shot. Oseltamivir is an oral medication, while zanamivir is inhaled.

Peramivir is intended for use by adult hospital patients who have uncomplicated flu, but can't take oral or inhaled drugs. Patients must have been symptomatic for no more than 2 days, according to the product's indications.

Peramivir has been approved in Japan and Korea. BioCryst estimates that more than 1 million patients have received peramivir treatment to date.

While treatments for flu are available, it is also adviseable to observe other practices such as observing good hygiene, consistently washing and sanitizing one's hands before eating, and covering the mouth and nose while sneezing to lessen one's vulnerability to the disease. Eating healthy food, getting proper sleep, and getting enough exercise are among the tested immune system boosters that would strengthen the body's defense against viral infections.

Meanwhile, a new antibacterial drug was also approved by the FDA. Ceftolozane/ tazobactam whose approval, according to Infectious Diseases Society of America (IDSA), is an important milestone in the medical field. The agency approved the combination of ceftolozane, a cephalosporin antibacterial drug, and tazobactam, a beta-lactamase inhibitor, which will be sold as Zerbaxa and used to treat complicated intra-abdominal infections and complicated urinary tract infections. Ceftolozane/tazobactam got approval under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act as "an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection,"

"The FDA approval of several new antibacterial drugs this year demonstrates the agency's commitment to increasing the availability of treatment options for patients and physicians," according to Edward Cox, MD, of the agency's Center for Drug Evaluation and Research.

"We must continue to help foster the development of new antibacterial drugs and encourage prudent use of existing treatments to conserve their utility," Cox said in a statement.

On the other hand, the fight is not over, the IDSA said.

"Even this important approval doesn't address all of our antibiotic needs," the society statement said. "Patients still face life-threatening infections for which additional new antibiotics are urgently needed."

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