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The Food and Drug Administration on Wednesday approved the first new anti-flu pill in two decades, which has made it easier for children to get older.
The drug, to be marketed globally by Shionogi & Co. and Roche Holding, gained FDA approval just as the winter flu season begins. Developer Shionogi won approval for the treatment, called Xofluza, in the case of the drug, which is known as Roche's Tamiflu with anti-viral activity.
The tablet gives a new weapon, but studies reveal a tendency for viruses to develop reduced susceptibility to the new treatment. It is not yet clear that drug-evading germs are capable of spreading easily between people, causing potency to wane, Roche said. Lab tests indicate that Xofluza can also weaken activity against the typically less-common influenza B strain.
"A new antiviral against fluids is one of the first, but it is a couple," said William Schaffner, professor of infectious diseases at Vanderbilt University School of Medicine in Nashville. of cautions, namely, resistance to influenza B strains, "he said in an interview with the Centers for Disease Control and Prevention in Atlanta, where he sits on an immunization advisory panel.
The 2017-2018 Northern Hemisphere flu is particularly bad, leading to some 900,000 hospitalizations, including 183 pediatric deaths, in the U.S. alone.
Population aging and the demand for flu immunizations, treatments and diagnoses will help push up the global influenza market by 3 percent a year to reach $ 6.5 billion by 2022, BCC Research estimated in April. Shionogi will manufacture the drug in Japan, with the plan to transfer the manufacturing to Basel, Switzerland-based Roche, which in Japan and Taiwan.
Tamiflu sales fell 33 percent to 535 million Swiss francs ($ 537 million) in 2017 after generic versions approved in the US in August 2016 increased competition. Revenue peaked at 3.2 billion francs in 2009, when a novel H1N1 swine flu virus sparked the first flu pandemic in four decades.
"Xofluza is an excellent drug," said Atsushi Seki, an analyst with UBS in Tokyo. Still, its "commercial potential is moderate," he said, noting that the potential for drug resistance represents a risk for sales, which does not vary in the severity of flu seasons, which drives prescriptions. The past Southern Hemisphere has a relatively mild winter season.
Patient studies indicated a potential for viruses with reduced susceptibility to 2.2 percent to 9.7 percent of adolescents and adults, and almost 20 percent of pediatric recipients, according to the New England Journal of Medicine last month. More of the medicine might be needed to stop influenza B, according to a paper published in the journal Antiviral Research.
The FDA approved Xofluza to tackle uncomplicated flu in people 12 years and older. It's the first treatment "to demonstrate a clinically meaningful benefit for people highly vulnerable to serious influenza complications," Roche said in an Oct. 17 statement. The drug is being tested in a late-stage study of pediatric patients.
It's taken as a single dose, unlike Tamiflu, which is usually taken twice a day for five days. The simpler rule was that this patient compliance could encourage drug-resistant viruses to emerge, and could ease the medication's distribution during a pandemic.
These benefits can be seen in the standard of care for uncomplicated flu cases, said Takeki Uehara, who led research and development at Osaka-based Shionogi. The Japanese drugmaker began working on the project in 2007, utilizing a library of molecules screened for activity against a particular vulnerability inherent in flu.
Taken together, Xofluza and Tamiflu may have a "synergistic effect" without any adverse interactions, although additional patient studies are needed to confirm a clinical benefit, Uehara said in an interview. Xofluza 10 days before exposure can be successfully stave off the respiratory infection.
There is also a plan to test Xofluza in hospitalized patients with influenza in combination with other anti-flu drugs, according to Roche.
Unlike Tamiflu, which works by blocking a protein called neuraminidase, it is a novel method that Xofluza targets an enzyme called cap-dependent endonuclease, which is needed to synthesize the proteins used to form new viruses.
"I'm excited about this agent because it's a novel mechanism in antiviral action," said Frederick Hayden, a professor of medicine and pathology at the University of Virginia's School of Medicine in Charlottesville, who was among a group of researchers studying Xofluza. the US and Japan. "We have not had any new influenza drugs in the world of how they work in inhibiting the virus in about 20 years."
Bloomberg's Tim Loh, Ayaka Maki and Naomi Kresge contributed.
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