By Jason Gale
Oct. 26 (Bloomberg) -- Hospitals in the U.S., where hundreds of swine flu patients are being admitted daily, may use BioCryst Pharmaceutical Inc.’s antiviral drug peramivir in some cases under a Food and Drug Administration emergency ruling.
The FDA authorized on Oct. 23 the use of an intravenous version of the medicine, which is in final-stage testing in the U.S., to treat confirmed or suspected swine flu in children and adults who may not benefit from conventional treatments or where an infusion is likely to be more beneficial.
The decision will spur wider use of BioCryst’s unapproved drug and give physicians an alternative to Roche Holding AG’s Tamiflu tablet and GlaxoSmithKline Plc’s inhaled medicine Relenza. Since Aug. 30, more than 8,200 people have been hospitalized for influenza in the U.S., according to government estimates. In severe cases, patients are too ill to swallow a pill or inhale powder, doctors said.
“The fact that peramivir can be given intravenously is a definite advantage, particularly for patients in intensive care,” said Dominic Dwyer, professor of immunology and infectious diseases at the University of Sydney, in a telephone interview today.
Production of about 130,000 courses of intravenous peramivir is under way in anticipation of government orders and more can be made if required, the company said in an Oct. 23 statement. A course comprises 600 milligrams given in a once- daily infusion for five days.
The company, based in Birmingham, Alabama, said it has donated about 1,200 courses of peramivir to the Department of Health and Human Services and is prepared to deliver more.
BioCryst Shares
BioCryst shares have surged more than fivefold to $9.66 since the new H1N1 influenza strain was reported in Mexico and the U.S. in late April and reached a three-year high of $12.80 on Aug. 26.
BioCryst’s partner, Osaka-based Shionogi & Co., which is preparing to file for regulatory approval in Japan this year, climbed 70 yen, or 3.4 percent, to 2,105 yen on the Tokyo stock exchange today. The shares have risen 23 percent since April 23.
The pandemic virus drove a 15-fold increase in intensive care admissions for viral lung inflammation in Australia and New Zealand during the Southern Hemisphere’s winter flu season. At the peak, swine flu patients filled 8.9 percent to 19 percent of all intensive-care hospital beds in each state of Australia and New Zealand, according to an Oct. 8 study in the Journal of the American Medical Association.
“In our experience with flu last winter, something that you could give intravenously would be useful,” Dwyer said.
Neuraminidase Inhibitor
Like Tamiflu and Relenza, peramivir works by blocking a protein on the surface of influenza particles called neuraminidase, which allows the virus to escape from infected cells to other cells in the body.
As part of the conditions of the FDA’s so-called Emergency Use Authorization, health-care providers must report adverse events and all medication errors associated with peramivir to the regulator within seven days.
“It’s reasonable to make this drug available during outbreaks and to expect clinicians to fill out adverse drug reports for investigational agents,” said Steven M. Opal, professor of medicine at Brown Medical School and chief of infectious diseases at Memorial Hospital in Pawtucket, Rhode Island. “We do this all the time in clinical trials.”
To contact the reporter on this story: Jason Gale in Singapore at j.gale@bloomberg.net.
Last Updated: October 26, 2009 05:19 EDT
No comments:
Post a Comment