FDA panel recommends replacing original COVID-19 vaccines with bivalent Omicron shots
The FDA's Vaccines and Related Biological Products Advisory Committee unanimously recommended replacing Pfizer and Moderna's original COVID-19 vaccine formulations, which were the first two vaccines available in the US, with the new bivalent Omicron shots (authorized only as boosters at the time this article went to press). If the FDA accepts the recommendation, the vaccines developed in 2020 to protect against the original COVID-19 strain may be phased out, and the bivalent Omicron shots that target both the Omicron BA.4/5 subvariants and the original SARS-CoV-2 strain will be administered instead.
The proposed change will only affect people who have not yet received their two-dose primary vaccination series. The panel members agreed that the change would simplify the US COVID-19 vaccination program.
Evusheld not currently authorized for emergency use in US
The FDA announced in late January 2023 that monoclonal antibody treatment Evusheld (tixagevimab co-packaged with cilgavimab), which in December 2021 received emergency use authorization for pre-exposure prophylaxis of COVID-19 in immunocompromised patients and certain other individuals, is not currently authorized for emergency use in the US because data show it is unlikely to protect against currently dominant SARS-CoV-2 variants. The agency revised the emergency use authorization for Evusheld to limit its use to when the combined frequency of SARS-CoV-2 variants that are not susceptible to the product in the US is less than or equal to 90%. The FDA's action to limit the use of Evusheld prevents exposing patients to possible adverse reactions at a time during which the monoclonal antibody treatment protects against fewer than 10% of variants circulating in the country.
Rybelsus now approved as first-line treatment option for T2DM in adults
The FDA approved a labeling update for Rybelsus (semaglutide) 7 mg and 14 mg tablets, allowing use as a first-line treatment option for adults with type 2 diabetes mellitus (T2DM). It is the first and only glucagon-like peptide-1 (GLP-1) analog in pill form and is indicated along with diet and exercise to improve glycemic control in adults with T2DM.
Rybelsus labeling states it is not known if the drug can be used in people who have had pancreatitis. The drug is not for use in people with type 1 diabetes mellitus. Rybelsus may cause possible thyroid tumors, including cancer, and other serious adverse reactions. Rybelsus is a product of Novo Nordisk.
FDA approves two-drug rescue inhaler for asthma in adults
The FDA approved Airsupra, a pressurized metered-dose inhaler containing albuterol and budesonide, for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbation in adults with asthma. Airsupra was developed by AstraZeneca and Avillion.
The approval was based on the results of two phase 3 trials, MANDALA and DENALI. In MANDALA, the Airsupra combination inhaler's efficacy and safety were compared with albuterol rescue alone in adults, adolescents, and children with moderate-to-severe asthma. Use of the combination inhaler resulted in a significant reduction in the risk of severe exacerbation in adults and adolescents. In DENALI, a significant improvement in lung function was observed in patients with mild-to-moderate asthma randomized to the dual inhaler compared with those on its individual components or placebo.
Safety and tolerability of the two-drug inhaler are consistent with the known profiles of the components. The most common adverse reactions include headache, oral candidiasis, cough, and dysphonia.