WASHINGTON (AP) — GlaxoSmithKline’s IV drug for COVID-19 should no longer be used because it is likely ineffective against the omicron subvariant, which now makes up most U.S. cases, federal health officials said Tuesday.
The Food and Drug Administration announced that the company’s antibody drug sotrovimab is no longer approved to treat patients in a U.S. state or territory. The decision was anticipated as the FDA had repeatedly restricted the drug’s use in the Northeast and other regions when 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 public health officials. Some experts have warned of a BA.2-driven surge similar to that which has hit European countries, although case numbers in the US have yet to rise.
The drug, from Glaxo and co-developer Vir Biotechnology, is the latest antibody drug being made sideline by the mutating coronavirus that previously made drugs from Eli Lilly and Regeneron obsolete. The FDA withdrew their approval in January after concluding they were ineffective against the original version of omicron.
The decision leaves doctors and hospitals with just one antibody to use against routine COVID-19 cases: another Eli Lilly drug that regulators say appears effective against BA.2.
Doctors can also prescribe antiviral pills that are unaffected by the omicron mutations, which mainly affect the virus’ distinctive spike protein. Pfizer and Merck’s pills were mostly supplied to chain pharmacies and medical clinics in hopes of getting them to patients soon enough for them to take effect.
The federal government has bought almost $2 billion worth of Glaxos drug and has shipped more than 900,000 doses to US states since last fall.
London-based Glaxo announced last month that it was investigating a higher dose of the antibody against BA.2. But the FDA would have to review and approve the company’s application before giving consent to resume use in the United States
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 – like a virus or bacteria – but the drugs have to be reformulated as the coronavirus mutates repeatedly.
The drugs are prescribed for early use in people with recent COVID-19 infection who are at increased risk of serious illness or death, including the elderly or people with diabetes, heart disease and other common health conditions.
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