FDA approves drug for sepsis

Associated Press

WASHINGTON — The government approved a drug Wednesday that could save tens of thousands of lives a year from sepsis — the first treatment to directly attack these overwhelming bloodstream infections.

Doctors call Xigris a breakthrough, and Eli Lilly &Co. pledged to ship the medicine to hospital intensive care units within days.

"Sepsis is a huge public health problem," said Dr. Gordon Bernard, who led clinical trials of the medication. "This drug, although not a cure-all — it doesn’t save everyone — it reduces the mortality, and it’s the only drug ever shown to do that."

The Food and Drug Administration approved Xigris as a treatment for the most severe sepsis patients, those deemed least likely to survive. When given to such people, the drug can cut the chances of death by 13 percent.

"We’re talking about tens of thousands of lives per year potentially saved by this product if used appropriately," said Dr. Jay Siegel, FDA’s director of blood therapies.

Sepsis is a bacterial infection of the bloodstream that strikes about 750,000 Americans a year. Some 225,000 of them die when the infection sets off a chain of chemical reactions that destroy their organs.

Sepsis can strike anyone. It can be a complication of trauma, surgery, pneumonia and numerous other illnesses. Patients are treated with antibiotics, fluids, ventilators for lung failure, and other supportive care.

But until now, there has been no drug that directly attacks the way sepsis destroys organs, by causing inflammation and blood clots.

Overall, the drug reduced mortality by 6 percent. But the FDA looked more closely at how ill each patient was, and found that Xigris lowered mortality by 13 percent in those who initially had been deemed at highest risk of death. In lower-risk patients, the drug seemed to make no difference.

Who is a high-risk sepsis patient? Among the criteria are patients with underlying chronic illnesses before sepsis struck; those in intensive care, on ventilators or whose blood pressure shows a severe response to sepsis; and older patients.

Because Xigris works by interfering with blood clotting, it can cause severe bleeding, including strokes, the FDA warned. In clinical trials, serious bleeding occurred in 2.4 percent of patients.

No one yet knows if Xigris will help children with sepsis, the FDA cautioned. Lilly agreed to FDA requests to study Xigris in children, and to further low-risk adult sepsis patients to tease out whether it really makes a difference for them.

Each patient’s weight and extent of disease determine the dose, but a typical treatment will cost about $6,800, a Lilly spokesman said.

Copyright ©2001 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

Talk to us

> Give us your news tips.

> Send us a letter to the editor.

> More Herald contact information.

More in Local News

A Cessna 150 crashed north of Paine Field on Friday evening, Feb. 16, 2024, in Mukilteo, Washington. The pilot survived without serious injury. (Courtesy of Richard Newman.)
‘I’m stuck in the trees’: 911 call recounts plane crash near Paine Field

Asad Ali was coming in for a landing in a Cessna 150 when he crashed into woods south of Mukilteo. Then he called 911 — for 48 minutes.

Snohomish County likely to feel more like winter, beginning Monday

Get ready for a mix of rain and snow this week, along with cooler temperatures.

Anthony Boggess
Arlington man sentenced for killing roommate who offered shelter

Anthony Boggess, 33, reported hearing the voices of “demons” the night he strangled James Thrower, 65.

Mt. Pilchuck covered in snow is barely visible through the clouds as the sun breaks through illuminating raindrops as they fall off of the Mountain Loop Highway on Wednesday, Feb. 7, 2024 in Granite Falls, Washington. (Olivia Vanni / The Herald)
‘Active’ weather brings rain, snow, hail, fresh powder to Snohomish County

Up to an inch of snow could accumulate in the lowlands. Three inches of rain could fall in Darrington. And Stevens Pass is “doing quite well.”

Joanne Fisher, right, a meat wrapper with the Marysville Albertsons, hands a leaflet to a shopper during an informational campaign on  Wednesday, Nov. 9, 2022. Fisher was one of about a dozen grocery store workers handing out leaflets to shoppers about the proposed merger between Albertsons and Kroger. (Mike Henneke / The Herald)
US sues to block merger of grocery giants Kroger, Albertsons

Grocery workers in Snohomish County and elsewhere have argued the merger would stymie competition and hurt workers.

The Senate Ways and Means Committee during its meeting on Monday, Feb. 26, 2024, where the panel indicated it would not move ahead with legislation to cap residential rent increases at 7%. The move effectively killed the bill for the 2024 legislative session. (Bill Lucia/Washington State Standard)
Plan for 7% statewide cap on rent increases fails in Olympia

State Sen. June Robinson, D-Everett, told reporters the bill did not have enough support to move it forward.

People look out onto Mountain Loop Mine from the second floor hallway of Fairmount Elementary on Wednesday, Jan. 10, 2024 in Everett, Washington. (Olivia Vanni / The Herald)
Mining company ordered to stop work next to school south of Everett

After operating months without the right paperwork, OMA Construction applied for permits last week. The county found it still violates code.

Shoppers cross Alderwood Mall Parkway after leaving the mall and walking through its parking lot on Thursday, Feb. 15, 2024, in Lynnwood, Washington. (Ryan Berry / The Herald)
Lynnwood police seek 3 suspects after pursuit, brief shootout

The driver of a stolen car intentionally hit a teen boy Sunday, officers said. Police pursued the suspects near I-5.

Starbucks employee Zach Gabelein outside of the Mill Creek location where he works on Friday, Feb. 23, 2024 in Mill Creek, Washington. (Olivia Vanni / The Herald)
‘We cannot keep up’: Mill Creek Starbucks workers file for unionization

The cafe’s crew joins the ranks of the 624 stores nationwide, including two other locations in Snohomish County.

The Nimbus Apartments are pictured on Wednesday, March 1, 2023, in downtown Everett, Washington. (Ryan Berry / The Herald)
Snohomish County has the highest rent in the state. Could this bill help?

In one year, rent for the average two-bedroom apartment in Snohomish County went up 20%. A bill seeks to cap any increases at 7%.

The Westwood Rainier is one of the seven ships in the Westwood line. The ships serve ports in the Pacific Northwest and Northeast Asia. (Photo provided by Swire Shipping)
Westwood Shipping Lines, an Everett mainstay, has new name

The four green-hulled Westwood vessels will keep their names, but the ships will display the Swire Shipping flag.

A Snohomish County no trespassing sign hangs on a fence surrounding the Days Inn on Monday, Feb. 12, 2024 in Everett, Washington. (Olivia Vanni / The Herald)
Meth cleanup at Edmonds motel-shelter made matters worse, report says

Contamination has persisted at two motels Snohomish County bought to turn into shelters in 2022. In January, the county cut ties with two cleanup agencies.

Support local journalism

If you value local news, make a gift now to support the trusted journalism you get in The Daily Herald. Donations processed in this system are not tax deductible.