Myfembree (Myovant/Pfizer), an oral fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix, the estrogen estradiol, and the progestin norethindrone acetate, has been approved by the FDA for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the second product to be approved in the US for this indication; Oriahnn, which contains the GnRH receptor antagonist elagolix in combination with estradiol and norethindrone acetate, was approved earlier. Relugolix was approved for...

The FDA has approved Lybalvi (Alkermes), a fixed-dose combination of the second-generation antipsychotic olanzapine (Zyprexa, and generics) and samidorphan, a new opioid antagonist, for treatment of adults with schizophrenia or with manic or mixed episodes of bipolar I disorder. The addition of samidorphan is intended to mitigate the weight gain that occurs with olanzapine. This is the first FDA approval for samidorphan.

Oriahnn (Abbvie), a fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist elagolix, the estrogen estradiol, and the progestin norethindrone acetate copackaged with elagolix alone, has been approved by the FDA for oral treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the first product to be approved in the US for this indication. Elagolix (Orilissa) has been available since 2018 for treatment of moderate to severe pain associated with endometriosis. The GnRH receptor antagonist...

The FDA has approved abemaciclib (Verzenio – Lilly), an oral cyclin-dependent kinase (CDK) 4/6 inhibitor, for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Abemaciclib is the third CDK 4/6 inhibitor to be approved in the US for this indication.

The FDA has approved brigatinib (Alunbrig – Takeda), an oral tyrosine kinase inhibitor, for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). Translocations of the ALK gene are found in about 5% of lung cancers; they occur predominantly in nonsmokers with adenocarcinoma. Brigatinib is the third tyrosine kinase inhibitor to be approved for this indication; ceritinib (Zykadia) and alectinib (Alecensa) were approved earlier, and subsequently were...

The FDA has approved esketamine (Spravato – Janssen), an N-methyl-D-aspartate (NMDA) receptor antagonist, for intranasal treatment (in conjunction with an oral antidepressant) of adults with treatment-resistant depression (TRD). This is the first FDA approval for esketamine, which is the S-enantiomer of the intravenous anesthetic ketamine (Ketalar, and generics). In recent years, IV ketamine has been increasingly used (off-label) for treatment of TRD.

The FDA has approved ponesimod (Ponvory – Janssen), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Ponesimod is the fourth oral S1P receptor modulator to be approved in the US for once-daily treatment of relapsing forms of MS; ozanimod (Zeposia) and siponimod (Mayzent) are also approved for use in adults, and fingolimod (Gilenya) is indicated for use in patients...

The FDA has approved a fixed-dose combination of the opioid receptor antagonist naltrexone (ReVia, and others) and the antidepressant and smoking cessation agent bupropion (Wellbutrin SR, Zyban, and others), as Contrave (Orexigen/Takeda) for weight loss. The combination was approved for use as an adjunct to diet and increased physical activity in patients with a body mass index (BMI) ≥30 kg/m2 or a BMI ≥27 kg/m2 and one or more weight-related comorbidities such as hypertension, diabetes, or dyslipidemia. Naltrexone/bupropion is not a controlled...

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide, previously approved by the FDA for treatment of type 2 diabetes as Victoza, has now also been approved at a higher dose as Saxenda (Novo Nordisk) for chronic weight management in adults with a BMI ≥30, or a BMI ≥27 with a weight-related comorbidity such as hypertension, dyslipidemia, or diabetes.

The FDA has approved Aptensio XR (Rhodes), an extended-release formulation of methylphenidate hydrochloride, for treatment of attention-deficit/hyperactivity disorder (ADHD). The Aptensio XR capsules contain multilayer beads designed to provide both a rapid onset and a long duration of action. This formulation of methylphenidate has been available in Canada as Biphentin since 2006.