December Rx Product News

Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate (Menveo)

Manufactured by GSK

The FDA approved a new single-vial presentation of meningococcal (Groups A, C, Y, and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine (Menveo) for individuals aged 10 to 55 years for the prevention of invasive meningococcal disease. The medication was originally presented in 2010 as a 2-vial vaccine that will remain available for use in individuals aged 2 months to 55 years. The 1-vial presentation is more convenient for health care providers and is expected to be widely available by mid-2023, according to GSK. In clinical studies, investigators found no notable differences in the frequency and severity of adverse events between those who received the single-vial and those who received the 2-vial presentation.

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gsk.com

Tirzepatide (Mounjaro)

Manufactured by Eli Lilly and Company

The FDA has granted fast-track designation to tirzepatide, which is being investigated for individuals who are obese or overweight and have weight-related comorbidities. The drug is not indicated for individuals who are obese or overweight and have type 2 diabetes. It is meant to be an addition for individuals on a reduced-calorie diet engaged in increased levels of physical activity. The decision was based on the SURMOUNT-1 (NCT04184622) trial evaluating the efficacy and safety of the drug against placebo with coprimary end points of superiority of the 10- and/or 15-mg dose at reducing bodyweight by 5% or more from baseline at 72 weeks compared with placebo.

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lilly.com

Dupilumab (Dupixent)

Manufactured by Regeneron Pharmaceuticals, Sanofi

The FDA has approved dupilumab (Dupixent) for the treatment of adults with prurigo nodularis, the first such drug in the United States. A 300-mg dose of dupilumab is administered via subcutaneous injection with pre-filled pens or syringes every 2 weeks after the loading dose at different sites in individuals aged 18 years or older. The approval was based on data from the phase 3 LIBERTY-PN PRIME (NCT04183335) and PRIME2 (NCT04202679) trials, which analyzed the drug’s efficacy and safety. The primary end point of both trials analyzed the proportion of individuals with a clinically meaningful improvement in itch from baseline at 24 weeks (PRIME) and 12 weeks (PRIME2).

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dupixent.com

Cobas SARS-CoV-2 Qualitative Test

Manufactured by Roche

Roche has received an FDA 510(k) clearance for its cobas SARS-CoV-2 Qualitative Test. It is the first COVID-19 polymerase chain reaction test performed on an automated and high-throughput platform. It is cleared for use on cobas 6800 and 8800 systems and is intended for detection of SARS-CoV-2 in nasal and nasopharyngeal samples. The test is for individuals whose health care providers suspect they have COVID-19. The test has been available under the emergency use authorization since March 2020, but the new clearance is based on a comprehensive package submitted to the FDA that includes analytical and clinical studies.

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roche.com