The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly), which was previously approved by the FDA for treatment of moderately to severely active rheumatoid arthritis and treatment of COVID-19 in certain hospitalized adults, has now been approved for treatment of severe alopecia areata in adults. Baricitinib is the first systemic treatment to be approved in the US for this indication.

Omalizumab (Xolair – Genentech), a recombinant anti-IgE monoclonal antibody FDA-approved for treatment of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic urticaria, has now also been approved for use in conjunction with food allergen avoidance to reduce IgE-mediated food allergic reactions caused by accidental exposure in patients ≥1 year old. Omalizumab is the first drug to be approved in the US to reduce allergic reactions to more than one food. Palforzia, an oral peanut allergen powder, was approved in 2020 to mitigate allergic reactions caused by...

The FDA has approved vamorolone (Agamree – Catalyst), an oral corticosteroid, for treatment of Duchenne muscular dystrophy (DMD) in patients ≥2 years old. Vamorolone is the second oral corticosteroid to be approved in the US for treatment of DMD; deflazacort (Emflaza) was approved in 2017.

The FDA has approved vonoprazan (Voquezna – Phathom), a potassium-competitive acid blocker, for healing and maintenance of healing of all grades of erosive esophagitis and relief of associated heartburn in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection in adults.

The FDA has approved sotagliflozin (Inpefa – Lexicon), an oral sodium-glucose cotransporter 1 and 2 (SGLT1/2) inhibitor, to reduce the risk of hospitalization for heart failure (HF), urgent HF visits, and cardiovascular death in adults with either HF (with any left ventricular ejection fraction [LVEF]) or type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular risk factors. Sotagliflozin is the first dual SGLT1/2 inhibitor to be approved in the US. Unlike SGLT2 inhibitors, it is not FDA-approved to improve glycemic control in adults with type 2 diabetes....

Atogepant (Qulipta – Abbvie), an oral small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant"), has been approved by the FDA for prevention of episodic migraine in adults. It is the second oral CGRP receptor antagonist to be approved in the US for this indication; the first was rimegepant (Nurtec ODT), which is also approved for acute treatment of migraine. Parenteral CGRP monoclonal antibodies are approved for prevention of migraine (see Table 3).

The FDA has approved Trudhesa (Impel Neuropharma), a new dihydroergotamine nasal spray product, for acute treatment of migraine with or without aura in adults. Another dihydroergotamine nasal spray (Migranal, and generics) has been available for many years for the same indication.

The injectable interleukin (IL)-23 antagonist risankizumab-rzaa (Skyrizi – Abbvie) has been approved by the FDA for treatment of moderately to severely active Crohn's disease (CD) in adults. Risankizumab was approved earlier for treatment of plaque psoriasis and psoriatic arthritis.

The FDA has approved fenfluramine oral solution (Fintepla – Zogenix) for treatment of seizures in patients ≥2 years old with Dravet syndrome. It is the third drug to be approved for this indication. Stiripentol (Diacomit) and cannabidiol (Epidiolex), a purified product derived from marijuana, were approved earlier.

View the Table: Correct Use of Inhalers for COPD