Federal regulators rushed through an emergency authorization of intravenous peramivir, which is made by BioCryst Pharmaceuticals, just days after lawmakers pressed Health and Human Services Secretary Kathleen Sebelius for a green light. The authorization late Friday gives physicians the authority to use the IV antiviral when Relenza or Tamiflu either don't appear to help or when patients can't physically swallow or inhale them--not uncommon for the most severe cases.
The move to approve the late-stage therapy came just ahead of President Barack Obama's decision to declare the pandemic a national emergency. While most cases of swine flu have been mild, supplies of new flu vaccines are arriving only sporadically, leaving health officials concerned about the likelihood of a rise in hospitalizations as the outbreak spreads. It's also likely that doctors will be forced to deal with resistance to Tamiflu as the swine flu virus adapts and evolves.
Reuters reports that the FDA could also approve other experimental meds, including Biota's laninamivir and T-705, or favipiravir, from Toyama Chemical. Researchers have late-stage data on laninamivir, in which a single dose performed as well as five days treatment with Tamiflu. Analysts also speculate that NexBio could eventually see an accelerated approval for FluDase, which stops the flu by blocking the body's molecular receptors. BioCryst, meanwhile, says it is completing production of approximately 130,000 courses of IV peramivir and is prepared to make more.
The long-anticipated second wave of the flu has spurred intense criticism of Sebelius' department, which had projected that a much larger quantity of flu vaccine would be available at this point. Sebelius blamed the black eye on manufacturers. "We were relying on the manufacturers to give us their numbers and as soon as we got numbers we put them out to the public. It does appear now that those numbers were overly rosy," Sebelius told reporters.