Formulary Watch

Bayer has received Fast-Track designation from the U.S Food and Drug Administration (FDA) for its investigational anticoagulant asundexian (BAY2433334). Asundexian is an oral factor XIa inhibitor currently under phase 2 trials for potential secondary thrombosis prevention in patients with non-cardioembolic ischemic stroke, atrial fibrillation, or recent myocardial infarction.

To receive Fast Track designation, a drug must treat a serious condition and fulfill an unmet medical need. If a drug ga

The FDA has approved Fleqsuvy (baclofen oral suspension) to treat spasticity resulting from multiple sclerosis (MS) and when it is associated with spinal cord injuries or other spinal cord disorders. Fleqsuvy, approved for use in adults, is a gamma-aminobutyric acid (GABA-ergic) agonist that offers relief of flexor spasms and concomitant pain, clonus and muscle rigidity.

Azurity Pharmaceuticals, the developer of Fleqsuvy, is a Massachusetts-based company that focuses on drugs for use in patient

Pfizer and BioNTech initiated an application yesterday (Feb. 1) for emergency use authorization (EUA) of their COVID-19 vaccine for children ages 6 months through 4 years.

The vaccine, sold under the brand name Comirnaty, is FDA-approved for use in individuals ages 16 years and older. On May 10, 2021, it received an EUA for children 12 through 15 years of age, and on October 29, the EUA was extended to include children as young as 5 years old. I

If the new authorization is granted, this will b

The FDA has approved Quviviq (daridorexant) tablets to treat adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. This is the first FDA-approved drug for Swiss biopharmaceutical company Idorsia. Quviviq is scheduled to be available in pharmacies in May 2022 pending controlled substance scheduling by the Drug Enforcement Agency.

Quviviq is a dual orexin receptor antagonist (DORA) that blocks neuropeptides orexin A and orexin B from binding to receptor sit

The FDA has added two new pediatric indications for Xarelto (rivaroxaban). The regulatory agency’s decision in late December 2021 makes Xarelto the first FDA-approved direct oral anticoagulant (DOAC) for prevention venous thromboembolism (VTE) in patients ages 2 years and older with congenital heart disease after undergoing the Fontan procedure.

The FDA also gave the go-ahead for Xarelto as a treatment of VTE and to reduce the risk of recurring VTE in patients from birth to less than 18 years o

The FDA has approved Adbry (tralokinumab-ldrm) injection for the treatment of moderate-to-severe atopic dermatitis in adults whose condition is not controlled with prescription topical agents or when topical therapies are not advisable.

Adbry joins IL-4 receptor antagonist Dupixent (dupilumab) as the second biologic FDA-approved to treat atopic dermatitis. The FDA approved Dupixent in 2017. The approval of Adbry was announced on Dec. 28, 2021. The new treatment is expected to be available in ph

The FDA has approved Leqvio (inclisiran) injection to be used in conjunction with diet and maximally tolerated statin therapy to lower LDL cholesterol in adults with familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL cholesterol. HeFH is a hereditary gene mutation that interferes with a person’s ability to clear cholesterol. Patients with HeFH typically have LDL cholesterol levels at least twice as high as normal