Lilly says antibody drug cuts COVID-19 hospitalization, may seek emergency use nod

By Deena Beasley

(Reuters) – Eli Lilly and Co on Wednesday said a single infusion of its experimental antibody treatment reduced the need for hospitalization and emergency room visits for clinical trial patients with moderate COVID-19.

The company said it will discuss the interim results, which have not yet been reviewed by outside experts, with global regulators. The New York Times reported that Lilly Chief Scientific Officer Daniel Skovronsky said the company would talk with the U.S. Food and Drug Administration about the possibility of an emergency use authorization.

The mid-stage study tested three different doses of LY-CoV555, a manufactured copy of a an antibody produced by a patient who recovered from COVID-19. Antibody treatments work by recognizing and locking onto foreign invaders to prevent infection of healthy cells.

Of the total 302 patients treated with the Lilly drug, five or 1.7%, had to be hospitalized or required an emergency room visit. That compared with 6% in the placebo group, Lilly said.

“These data are not a home run but … are among the most encouraging COVID treatment data we’ve seen, particularly given this is in mild-to-moderate outpatients where there has simply been no treatment progress until now,” Raymond James analyst Steven Seedhouse said in a research note.

Oddly, only the middle 2,800-milligram dose achieved the trial’s main goal of reducing the amount of virus detected in patients compared with a placebo 11 days after treatment. Lilly said most trial participants, including those given a placebo, had completely cleared the virus by day 11. Some analysts suggested that future studies may want to use an earlier time point than 11 days.

Most hospitalizations occurred in patients with underlying risk factors such as obesity or advanced age. Lilly said future study would focus on people in these higher-risk groups.

No drug-related serious adverse events or trial deaths were reported.

Lilly said the trial will enroll 800 patients with mild-to-moderate COVID-19, with the next segment testing LY-CoV555 in combination with a second Lilly antibody, LY-CoV016, which binds to a different area of the coronavirus.

The antibodies, given by intravenous infusion, are also being tested for preventing COVID-19 in nursing home residents and staff and for treating patients already hospitalized with COVID-19.

Several companies including Regeneron Pharmaceuticals Inc and Vir Biotechnology are also testing antibody treatments for COVID-19.

Lilly’s shares were up 1.3% to $152.

(Reporting by Deena Beasley in Los Angeles and Manas Mishra in Bengaluru; Editing by Shinjini Ganguli and Bill Berkrot)

Black Americans hospitalized for COVID-19 at four times the rate of whites, Medicare data shows

(Reuters) – Black Americans enrolled in Medicare were around four times as likely as their white counterparts to be hospitalized for COVID-19, U.S. government data released on Monday showed, highlighting significant racial disparities in health outcomes during the pandemic.

“The disparities in the data reflect longstanding challenges facing minority communities and low income older adults,” said Seema Verma, administrator of the Centers for Medicare & Medicaid Services (CMS), which released the data.

The data showed that more than 325,000 Medicare beneficiaries were diagnosed with COVID-19 between Jan. 1 and May 16. Of those, more than 110,000 were hospitalized.

Black Americans had a hospitalization rate 465 per 100,000 Black Medicare beneficiaries. For other groups measured by CMS, the rates of per capita hospitalizations were 258 for Hispanics, 187 for Asians and 123 for whites.

Hospitalization rates were high for people who qualified for both the senior-focused Medicare program and the low-income-focused Medicaid program, at 473 per 100,000.

“Low socioeconomic status all wrapped up with racial disparities represents a powerful predictor of complications with COVID-19,” Verma said during a briefing about the data.

Medicare beneficiaries with end-stage kidney disease were hospitalized for COVID-19 at a rate of 1,341 per 100,000.

Medicare is a federal health insurance program designed primarily for seniors, as well as some people with disabilities and end-stage kidney disease.

Verma said that CMS’ ongoing push to reimburse providers based on health outcomes rather than paying them fixed fees for their services could help address racial disparities.

“When implemented effectively, (value-based reimbursement) encourages clinicians to care for the whole person and address the social risk factors that are so critical for our beneficiaries’ quality of life,” Verma said.

The data is based on claims filed for reimbursement from Medicare and therefore operates at a delay of several weeks.

(Reporting by Trisha Roy and Carl O’Donnell; Editing by Shinjini Ganguli and Cynthia Osterman)

Fourteen more fall sick from E. coli linked to romaine lettuce: CDC

Romaine lettuce grows near Soledad, California, U.S., May 3, 2017. REUTERS/Michael Fial

(Reuters) – Fourteen more sick people from eight U.S. states were added to an investigation of an E. coli outbreak linked to romaine lettuce, the U.S. Centers for Disease Control and Prevention (CDC) said on Friday.

Three more states – Mississippi, Tennessee and Wisconsin – reported ill people, the CDC said.

Eighty-four people infected with a strain of E. coli have been reported from 19 states, the CDC had said on Wednesday, in an update to its investigation into the outbreak.

The regulator has advised people not to eat or buy romaine lettuce, commonly used in salads, unless they can confirm it is not from the Yuma, Arizona growing region.

Forty-two people had been hospitalized, including nine who had developed a type of kidney failure, the CDC said.

(Reporting by Manas Mishra in Bengaluru; Editing by Sai Sachin Ravikumar)

Toxic gases from Indonesian volcano send 30 to hospital

A view of Mount Ijen, an active volcano and popular tourist destination for its sulphur mining, is seen the day after the crater was closed to visitors and many residents living on its slopes were forced to flee to avoid toxic gas near Bondowoso, East Java, Indonesia March 22, 2018 in this photo taken by Antara Foto. Antara Foto/Seno/via REUTERS

JAKARTA (Reuters) – An Indonesian volcano belched thick clouds of sulfuric gas on Wednesday, sending 30 people to hospital and prompting the closure of the popular tourist and mining site.

Nearly 200 people living on the slopes of Mount Ijen in East Java province were forced to evacuate.

“Because of this incident, the public – tourists or miners – are not allowed near the crater until further notice,” said Sutopo Purwo Nugroho, spokesman for the national disaster mitigation agency.

He added that many residents had experienced vomiting and difficulty in breathing.

There was no increase in seismic activity, Nugroho said.

The crater is a popular site for tourists and miners, who dig up hardening yellow sulfur to sell for use in everything from cosmetics to matchsticks.

The volcano regularly puffs out small amounts of noxious gases but the site stays open to the public.

Around five million of Indonesia’s 250 million people live and work near volcanoes, according to authorities, largely because of the fertile farming soil.

(This story has been refiled to correct typo in headline)

(Reporting by Kanupriya Kapoor; Editing by Nick Macfie)

U.S. flu-related hospitalizations highest in nearly a decade: agency

Emergency room nurse Christine Bauer treats Joshua Lagade of Vista, California, for the flu as his girlfriend Mayra Mora looks on in the emergency room at Palomar Medical Center in Escondido, California, U.S., January 18, 2018.

By Deena Beasley

(Reuters) – Flu activity worsened over the past week as more people headed to doctors’ offices and emergency rooms, with hospitalizations at the highest in nearly 10 years, U.S. health officials said on Friday.

Sixteen children died of the flu in the week ended Jan. 27, bringing total pediatric deaths to 53 for the season, according to the Centers for Disease Control and Prevention’s weekly report.

Out of every 100,000 people in the general population, an estimated 51.4 have been hospitalized for the flu, surpassing the rate in the last severe season of 2014/2015, when 710,000 were hospitalized and 148 children died. Adults aged 65 or older had the most hospitalizations, followed by those aged 50 to 64, and children below 5.

The dominant strain during this flu season is an especially nasty type called influenza A (H3N2) that in seasons past had been linked with severe disease and death, especially in the elderly and young.

“So far this year the cumulative rate of hospitalization is the highest since we began tracking in this way,” Dr. Anne Schuchat, acting director of the Centers for Disease Control and Prevention, told reporters on a conference call. The CDC began its current hospital flu surveillance program during the 2009-2010 H1N1 swine flu pandemic.

Schuchat was named acting CDC director earlier this week after Dr. Brenda Fitzgerald resigned from the post because of financial conflicts of interest, including purchases of tobacco and healthcare stocks while in office.

Flu is widespread in 48 states, down from 49 last week, with Oregon reporting less flu activity, the CDC said.

“We are not out of the woods yet,” Schuchat said, noting that sick people should stay home to avoid transmitting the virus to others, frequently wash hands and cover their mouth while coughing or sneezing.

The CDC official also said it was not too late to get a flu vaccine.

(Reporting by Deena Beasley; Editing by Richard Chang)