x

Health

US Pulls GSK’s COVID Drug as Omicron Sibling Dominates Cases

WASHINGTON — GlaxoSmithKline’s IV drug for COVID-19 should no longer be used because it is likely ineffective against the omicron subvariant that now accounts for most U.S. cases, federal health regulators said Tuesday.

The Food and Drug Administration announced that the company’s antibody drug sotrovimab is no longer authorized to treat patients in any U.S. state or territory. The decision was expected, because the FDA had repeatedly restricted the drug’s use in the Northeast and other regions as the BA.2 version of omicron became dominant.

The Centers for Disease Control and Prevention said Tuesday that BA.2 accounts for 72% of the COVID-19 cases sequenced by health authorities. Some experts have warned of a BA.2-driven surge similar to those that have hit European countries, though U.S. case counts have yet to rise.

The drug from Glaxo and codeveloper Vir Biotechnology is the latest antibody medication to be sideline by the mutating coronavirus, which previously rendered drugs from Eli Lilly and Regeneron obsolete. The FDA pulled their authorization in January after concluding they were ineffective against the original version of omicron.

The decision leaves doctors and hospitals with only one antibody still authorized for use against routine COVID-19 cases: a different Eli Lilly drug that regulators say appears effective against BA.2.

Doctors can also prescribe antiviral pills that haven’t been impacted by omicron’s mutations, which mainly affect the virus’ signature spike protein. The pills from Pfizer and Merck mostly have been shipped to pharmacy chains and medical clinics in hopes of getting them to patients early enough to work.

The federal government purchased nearly $2 billion worth of Glaxo’s drug, shipping more than 900,000 doses to U.S. states since last fall.

London-based Glaxo said last month it is studying a higher dose of the antibody against BA.2. But the FDA would need to review and authorize the company’s request before giving the OK to resume use in the U.S.

The antibody drugs are laboratory-made versions of virus-blocking proteins found in the human body. Each antibody is formulated to attack a specific invader — such as a virus or bacteria — but the medications need to be reformulated as the coronavirus repeatedly mutates.

The drugs are prescribed for early use in people with a recent COVID-19 infection who face increased risk of severe disease or death, including seniors or people with diabetes, heart disease and other common health problems.

RELATED

Robin Alderman faces an agonizing reality: Gene therapy might cure her son Camden’s rare, inherited immune deficiency.

Top Stories

Columnists

A pregnant woman was driving in the HOV lane near Dallas.

General News

NEW YORK – Meropi Kyriacou, the new Principal of The Cathedral School in Manhattan, was honored as The National Herald’s Educator of the Year.

Video

Alberto, Season’s First Named Tropical Storm, Dumps Rain on Texas and Mexico, Which Reports 3 Deaths

TAMPICO, Mexico (AP) — Tropical Storm Alberto rumbled toward northeast Mexico early Thursday as the first named storm of the season, carrying heavy rains that left three people dead but also brought hope to a region suffering under a prolonged, severe drought.

STUTTGART, Germany — A dramatic stoppage-time goal saw Hungary beat Scotland 1-0 at the European Championship on Sunday to wreck its opponent’s hopes of reaching the knockout stage of a major tournament for the first time in its history.

HOUSTON  — Gerardo Arteaga scored from the edge of the penalty area in the 69th minute and Mexico beat Jamaica 1-0 on Saturday night in its Copa America opener.

SKOPJE, North Macedonia (AP) — North Macedonia's center-right leader secured parliamentary approval to lead a new coalition government in a vote late Sunday.

JERUSALEM — Leaders of major churches have accused Israeli authorities of launching a “coordinated attack” on the Christian presence in the Holy Land by initiating tax proceedings against them.

Enter your email address to subscribe

Provide your email address to subscribe. For e.g. [email protected]

You may unsubscribe at any time using the link in our newsletter.