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New flu drug receives priority consideration by FDA



The U.S. Food and Drug Administration has given fast-track consideration for a drug that helps control flu symptoms after one dose.

The drugmaker, Genentech, said in a press release this week the federal agency has granted the company priority review consideration for baloxavir marboxil.

If approved, it would be the first oral, single dose antiviral designed specifically for influenza. The drug targets influenza A and B viruses, including oseltamivir-resistant strains and avian strains of H7N9 and H5N1.

"The severity of the recent flu season underscores the need for new options beyond currently available treatments, and if approved, baloxavir marboxil would be the first flu medicine with a novel proposed mechanism of action in nearly 20 years," Dr. Sandra Horning, chief medical officer and head of Global Product Development at Genentech, which is part of the Roche Group, said in a press release. "We look forward to working with the FDA during the review process."

The company said it expects a decision by the FDA by the end of the year.

In a priority review designation, the FDA determines that a drug has the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

In February, Japan approved the drug, which is being sold under the brand name XOFLUZA. Shionogi & Co., which discovered drug, is developing the medication globally with Roche Group, which includes Genentech in the United States.

A Phase III clinical trial, called Capstone, has been conducted in the United States and Japan. There were 1,494 participants between age 12 and 64 in the United States. The one-dose medication cut the time people were sick from 80.2 hours to 53.7 hours, cut a fever from an average of 42 hours to 24.5 hours and reduced the time viruses continued to be released by the body from four days to one.

Baloxavir marboxil had lower overall incidence of adverse events -- 20.7 percent -- when compared to placebo at 24.6 percent or oseltamivir, marketed as Tamiflu, at 24.8 percent. The most common adverse events reported were diarrhea, bronchitis, nausea and sinusitis. Oseltamivir was given twice daily for five days.

The drug is also undergoing a Phase II trial in pediatric populations with influenza.

Unlike other currently available antiviral treatments, baloxavir marboxil is designed to inhibit the cap-dependent endonuclease protein within the flu virus.

Tamiflu is among drugs are in a class called neuraminidase inhibitors, which help stop the virus from spreading inside the body and work best within a day or so of symptoms.

The others are Zanamivir, under the brand Relenza, which is inhaled, and peramivir, with the trade name Rapivab, as an injectable by a health provider. Relenza is not recommended for people with breathing problems, including asthma and COPD.

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