FONT-SIZE Plus   Neg

GSK Gets FDA Approval For Raxibacumab Anti-toxin To Treat Inhalational Anthrax

GlaxoSmithKline plc (GSK, GSK.L) announced Friday that the U.S. Food and Drug Administration has approved raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.

The company said that the effectiveness of raxibacumab is based solely on efficacy studies in animal models as it is not ethical or feasible to conduct controlled clinical trials with intentional exposure of humans to anthrax. The safety of raxibacumab has been studied in healthy adult volunteers, however, there have been no studies of raxibacumab in the pediatric population.

Dosing in pediatric patients was derived using modelling based on data in adults.

The company noted that Raxibacumab does not have direct antibacterial activity. Raxibacumab does not cross into the brain and does not prevent or treat anthrax meningitis. Raxibacumab should be used in combination with appropriate antibacterial drugs.

Raxibacumab is the first monoclonal anti-toxin to be approved for inhalational anthrax. Anthrax is a rare and lethal disease, caused by a toxin producing bacterium. While antibiotics target the anthrax bacteria, raxibacumab offers an additional mechanism by blocking the activity of the anthrax toxin, which plays a key role in the progression of the disease. Raxibacumab demonstrated an improved survival rate over control in two relevant animal models both in combination with antibiotics and alone.

The company noted that the recommended adult dosage of raxibacumab is a single dose of 40 mg/kg given intravenously over a period of two hours and 15 minutes. Administer diphenhydramine within an hour of treatment to reduce the risk of infusion reactions.

Raxibacumab is not approved or licensed in Europe and currently is not approved in other parts of the world for the treatment or prophylaxis of patients with inhalational anthrax, the company said.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
German conglomerate Bayer AG, which is in $66 billion deal to acquire U.S. seed firm Monsanto Co., on Wednesday raised its core earnings forecast for fiscal 2016 after reporting higher profit and sales in its third quarter. Further, the company maintained guidance for adjusted EBITDA, a key earnings metric, and sales. The stock is currently trading 3 percent lower in Germany. Aerospace and defense major Airbus Group SE Wednesday reported a decline in nine-month profit and new orders, while revenues were stable. The weak results reflected the ongoing ramp-up and transition from current to new aircraft models. Looking ahead, for fiscal 2016, the company continues to expect stable adjusted earnings per share and EBIT. Apple Inc. (AAPL) reported its third straight quarter of iPhone sales and revenue declines after the market closed on Tuesday. The tech giant's fourth-quarter profit trumped Wall Street expectations, while revenues fell short. Although, Apple reported its third straight year-over-year decline in iPhone...
comments powered by Disqus
Follow RTT