Mirabegron (mir a beg’ ron; Myrbetriq [meer BEH trick] – Astellas), a beta-3 adrenergic agonist, has been approved by the FDA for the treatment of overactive bladder. It is the first beta-3 adrenergic agonist to be approved for any indication in the US. Mirabegron has been marketed in Japan since 2011. OnabotulinumtoxinA (Botox) was also recently approved by the FDA for treatment of overactive bladder and will be reviewed in a future issue.

The FDA has amended its Emergency Use Authorizations (EUAs) for the bivalent mRNA COVID-19 vaccines (original and Omicron BA.4/5 strains) manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit their use for all doses administered to persons ≥6 months old. The monovalent Pfizer and Moderna vaccines are no longer authorized for use in the US

The FDA has approved Epclusa (Gilead), a fixed-dose combination of sofosbuvir (Sovaldi) and velpatasvir, a new direct-acting antiviral agent, for oral treatment of chronic hepatitis C virus (HCV) infection. Epclusa is the first oral combination to be approved for treatment of all six major HCV genotypes.

The FDA has approved tirzepatide (Mounjaro – Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve glycemic control in adults with type 2 diabetes. Tirzepatide, which is injected subcutaneously once weekly, is the first dual GIP/GLP-1 receptor agonist to become available in the US. Selective GIP receptor agonists are not available in the US; GLP-1 receptor agonists have been available for years.

Raltegravir (Isentress - Merck), the first in a new class of oral HIV drugs called HIV-1 integrase strand transfer inhibitors (InSTI), has received accelerated FDA approval for use in combination therapy for treatment-experienced adults infected with HIV-1 strains resistant to multiple antiretroviral agents.

Maraviroc (Selzentry - Pfizer), the first CCR5 (CC chemokine receptor 5) antagonist has received the same FDA approval but is restricted to use in adults with CCR5-tropic HIV-1 ("R5 virus"). A commercial assay is available for R5 tropism.

Ophthalmic formulations of ketotifen fumarate (Zaditor), pemirolast potassium (Alamast) and nedocromil sodium (Alocril) have recently been approved by the FDA for use in adults and children with itching of the eyes due to allergic conjunctivitis.

The FDA has approved a higher-dose injectable formulation of the long-acting glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Ozempic) for treatment of type 2 diabetes in adults. A single SC injection of the new 8 mg/3 mL formulation delivers 2 mg of semaglutide.

The injectable glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide, which was approved by the FDA as Mounjaro for treatment of type 2 diabetes in 2022, has now been approved as Zepbound (Lilly) for chronic weight management in adults who have a BMI ≥30 kg/m2 or a BMI ≥27 kg/m2 and at least one weight-related comorbidity. The injectable GLP-1 receptor agonists liraglutide (Saxenda) and semaglutide (Wegovy) are approved for chronic weight management in patients ≥12 years...

The ophthalmic H1-antihistamine alcaftadine 0.25%, which has been available by prescription since 2011 for use in patients with allergic conjunctivitis, is now available without a prescription as Lastacaft Once Daily Relief (Allergan) for temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair, and dander in adults and children ≥2 years old. It is the third ophthalmic antihistamine to be approved for over-the-counter (OTC) use (see Table 1).

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) has been approved by the FDA to reduce the risk of major adverse cardiovascular events (MACE) in adults with established cardiovascular disease (CVD) and either obesity or overweight. Semaglutide is the first drug to be approved for cardiovascular risk reduction in this population. It is also approved in a lower-dose injectable formulation as Ozempic and in an oral formulation as Rybelsus (see Table 1).