Publication

Article

Pharmacy Times

December 2022
Volume88
Issue 12

December Rx Product News

Author(s):

Products include a vaccine for meningococcal disease and a new type of COVID-19 test.

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.

For More Information

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.

For More Information

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).

For More Information

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.

For More Information

roche.com

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