Rx Product News: April 2023

Zuranolone (SAGE-217/BIIB125)

From: Biogen and Sage Therapeutics

The FDA has accepted a new drug application for Biogen and Sage Therapeutics’ SAGE-217/BIIB125 (zuranolone) for the management of major depressive disorder and postpartum depression in adults. The drug is an investigational 14-day, once-a-day, rapid-acting oral treatment. Zuranolone is a neuroactive steroid that is a positive allosteric modulator used to alter the protein activity of γ-aminobutyric acid type A receptors. Using these receptors, the drug can rebalance dysfunctional neuronal networks, which regulate arousal behavior, cognition, mood, and other brain functions. The submission is based on 7 studies that evaluated the drug. The FDA has also granted the drug priority review, giving it a Prescription Drug User Fee Act action date of August 5, 2023.

For More Information:

biogen.com

Tezepelumab-ekko (Tezspire)

From: Amgen and AstraZeneca

The FDA has approved Amgen and AstraZeneca’s tezepelumab-ekko (Tezspire) pen for individuals 12 years and older with severe asthma. The new prefilled, single-use pen is intended for self-administration. The FDA first approved the drug in December 2021, and it is the only biologic approved for severe asthma with no phenotype or biomarker limitation within the approved label. Tezspire is a first-in-class human monoclonal antibody that works on the airway epithelium, the main source of inflammation and initial point of contact for allergens, pollutants, and viruses. It targets and blocks thymic stromal lymphopoietin, an epithelial cytokine on top of multiple inflammatory cascades, and triggers an overreactive immune response to allergic, eosinophilic, and other types of airway inflammations associated with severe asthma. The most common adverse events include arthralgia, back pain, and pharyngitis.

For More Information:

amgen.com

mRNA-1345

From: Moderna

The FDA has granted breakthrough therapy designation to an investigational respiratory syncytial virus vaccine candidate, mRNA-1345 from Moderna, for individuals 60 years and older. mRNA-1345 is a single messenger RNA (mRNA) sequence encoding for a stabilized prefusion F glycoprotein, using the same lipid nanoparticles as the company’s mRNA COVID-19 vaccines. The F glycoprotein is the surface of the virus that helps the virus enter host cells, whereas the prefusion conformation is a significant target of neutralizing antibodies. The designation was based on positive topline data from the ConquerRSV (NCT05127434) phase 3 pivotal efficacy trial. The FDA previously granted the mRNA-1345 vaccine candidate fast-track designation in August 2021.

For More Information:

amgen.com

Daprodustat (Jesduvroq)

From: GSK

The FDA has approved GSK’s daprodustat (Jesduvroq) for the daily management of anemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least 4 months. The oral, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) was the first drug to gain approval for the management of anemia in more than 30 years and is the only HIF-PHI approved in the United States. When inhibiting oxygen-sending prolyl hydroxylase enzymes, it has been found to stabilize hypoxia-inducible factors leading to the transcription of erythropoietin and other genes involved in the correction of anemia. The drug was developed to provide an oral option for individuals with anemia related to CKD.

For More Information:

gsk.com