Rx Product News: March 2023

Albuterol/Budesonide (Airsupra)

From: AstraZeneca

The FDA has approved albuterol/budesonide (Airsupra) from AstraZeneca for the prevention and management of bronchoconstriction on an as-needed basis. It was approved in the 180-g albuterol/160-g budesonide dosage. The rescue treatment works with albuterol, a short-actingβ2-agonist, and budesonide, an anti-inflammatory inhaled corticosteroid, to prevent the exacerbation of symptoms of moderate to severe asthma in adults. The most common adverse events included cough, dysphonia, headaches, and oral candidiasis.

For More Information:

astrazeneca.com

VIASURE Monkeypox Virus PCR Detection Assay

From: Becton, Dickinson and Company, and CerTest Biotec

The FDA has granted emergency use authorization to a molecular polymerase chain reaction (PCR) assay test from Becton, Dickinson and Company and CerTest Biotec for the detection of mpox (monkeypox) virus. The VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX could help prevent the global spread of the virus. The automated BD MAX System works by extracting nucleic acid and real-time PCR to produce results for up to 24 samples in under 3 hours. VIASURE Monkeypox Virus PCR Detection assay is available in a lyophilized format.

For More Information:

bd.com

Lecanemab (Leqembi)

From: Biogen Inc and Eisai Co, Ltd

The FDA has granted accelerated approval to lecanemab (Leqembi) from Biogen Inc and Eisai Co, Ltd to slow the progression of Alzheimer disease (AD). The action marks the second approval for a new class of medication that targets the fundamental pathophysiology of AD. It is indicated to treat mild cognitive impairment or the mild dementia stage of the disease. The most common adverse events included infusion-related reactions such as changes in blood pressure level, flu-like symptoms, nausea, and vomiting. Additionally, amyloid-related imaging abnormalities and headaches were associated with the drug. The potential associations with brain swelling and bleeding were also a concern.

For More Information:

eisai.com

Pentavalent Meningococcal Vaccine (MenABCWY)

From: Pfizer

The FDA has accepted for review a biologics license application for Pfizer’s investigational pentavalent meningococcal vaccine candidate (MenABCWY). Pfizer submitted the vaccine for the prevention of meningococcal disease, which is most commonly present in individuals aged 10 to 25 years. The vaccine candidate combines components of 2 vaccines that help protect against the meningococcal serogroups that cause most cases of invasive disease. If approved and recommended, the vaccine could be another routine recommendation option and potentially reduce the total number of doses needed to be fully vaccinated against the 5 serogroups.

For More Information:

pfizer.com