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NM to receive 10,000 doses of antibody

Copyright © 2020 Albuquerque Journal

Drugmaker Eli Lilly and Co. is offering a new drug to New Mexico that could keep thousands of high-risk COVID-19 patients out of the hospital. (Courtesy of Eli Lilly And Co.)

For weeks now, New Mexico’s struggle to contain the coronavirus has been a losing battle as both infections and deaths have soared.

Along with having one of the lowest number of hospital beds per capita and a high proportion of residents with chronic health conditions, the state is now a hot spot for new COVID-19 cases and deaths in the U.S.

But drugmaker Eli Lilly and Co. is offering some relief that could keep thousands of at-risk coronavirus patients out of the hospital – if they can get access to the one-time infusion within their initial seven or so days of infection.

The company has selected New Mexico to receive 10,000 doses of the company’s new antibody treatment, Bamlanivimab. That’s in addition to the 878 doses already allocated to the state by the federal government.

The synthetic antibody therapy has shown promise in reducing the severity of symptoms in high-risk patients with mild to moderate COVID-19 cases. The therapy could reduce the burden on New Mexico’s strained hospital systems.

The treatment is similar to the therapy developed by Regeneron Pharmaceuticals Inc. President Donald Trump praised Regeneron’s product after he recovered from COVID-19 in October. Both treatments were approved for emergency use by the Federal Drug Administration this month.

The logistics of administering the one-time intravenous infusions to symptomatic patients are still being ironed out.

But Dr. David Scrase, Gov. Michelle Lujan Grisham’s chief medical adviser on COVID-19, lauded the prospect of a new antibody treatment while the world awaits the arrival of a widespread vaccine.

“There’s not a lot of other good news out there in the next few weeks for New Mexico, I’m afraid,” said Scrase, who is the Cabinet secretary for the state’s Human Services Department. “This could be a really big deal if we can lower hospitalizations.”

Hospitalizations of COVID-19 patients over the past two weeks have increased 97%, spurring the state to open an alternate care site last week for recovering hospitalized patients at the Gibson Medical Center in Albuquerque. Deaths were up 68% over the prior two weeks, and new cases were up 125% over the same time period, according to the COVID Tracking Project.

Lilly in a news release Oct. 28 said it had signed a $375 million deal with the federal government to provide 300,000 doses of the antibody treatment, which has proven to be effective only on patients who have not been hospitalized. Patients aren’t supposed to pay out-of-pocket costs for the drug, but health care facilities may charge a fee for administering the drug.

Lilly representatives couldn’t be reached for comment last week, but Scrase said the company approached New Mexico several weeks ago about further distributing its treatment, in part because of how the state has managed the pandemic.

“They thought we had our act together,” Scrase said. The company cited the state’s public health orders, its information reporting systems and, he said, “the fact that our delivery system was coordinated.”

For instance, more than 60% of those people hospitalized with COVID-19 in New Mexico have received another drug, Remdesivir, which helps keep patients out of the ICU. It was also among the drugs Trump received.

“I think Lilly would like to expand its investigation of the drug to a more broader, more diverse set of individuals so New Mexico offers that,” Scrase said.

Most people who contract the virus in New Mexico recover on their own. As of Saturday, the DOH has designated 31,482 cases as recovered.

But nearly 20% of COVID-19 patients in New Mexico who have been hospitalized have died. On Tuesday, 21 of the 28 people who died had underlying health conditions and were hospitalized.

Under the protocol for administering Bamlanivimab, to be eligible for the one-hour intravenous treatment, a patient must be at least 12 years old, test positive and have one condition that puts them at high risk. These conditions include lung or heart disease, obesity, and being in a high-risk age group. The vast majority of deaths has been among people 50 and older.

The therapy is aimed at those who are at high risk of being hospitalized, and it would need to be given within seven days of an individual testing positive, Scrase said.

The national testing data so far is encouraging.

A preliminary analysis showed the risk of hospitalization or an emergency room visit was 1.6% – or five out of 309 people who received the infusion – compared to 6.3%, or nine out of 156 in a placebo group.

“If you are over 65 and test positive, your chances for all comers from being hospitalized is something like 14 or 15%, and it cuts it down to 5%. So it reduces it by about two-thirds,” Scrase told the Journal.

Those eligible would be under a doctor’s care and would go to a provider or a dedicated infusion center in an outpatient setting where they wouldn’t come into contact with immunosuppressed people also receiving infusions, such as those receiving chemotherapy.

One idea being floated: sending a mobile van around New Mexico towns to administer the treatments.

“You would go somewhere,” Scrase said, “And part of our job would be to set up lots of these ‘somewheres,’ and you would get an infusion of this drug over one hour, and you would be observed to make sure you didn’t have a reaction to the drug for an additional hour (at least).”

Dr. Jason Mitchell, chief medical officer for Presbyterian Healthcare Services, said a new outpatient COVID-19 infusion center is scheduled to open at Presbyterian Kaseman Hospital in December.

“This will provide important treatments to COVID-19 patients who can benefit from them, and by providing this in an outpatient setting it will also help us to free up more inpatient hospital beds,” Mitchell said through a spokeswoman. The center will offer Remdesivir and Bamlanivimab. Initially, Bamlanivimab will also be administered in the Emergency Department.

Eventually, clinicians will be able to refer patients who meet the criteria for one of the two treatments to the center.

Scrase said state health officials are expected to be meeting with Lilly representatives soon, and if all goes well, the treatment could be available as early as mid-December.

“One dose per person would allow us to treat another 10,000 COVID-positive individuals. If we were going to do 200 to 300 a day, that could have a significant impact on hospitalizations at the time we most need that impact,” he added. It wasn’t clear last week how many doses of the other antibody therapy, from Regeneron, might be arriving.

“We want to get as much treatment as we possibly can to New Mexicans to lower their rate of complications and hospitalizations and deaths, so we’ll be investigating every path,” Scrase said.

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