The FDA has approved a new plasma-derived von Willebrand factor/Factor VIII concentrate (Wilate – Octapharma) for treatment of spontaneous and trauma-induced bleeding episodes in patients with von Willebrand disease.

The FDA has approved intravenously administered recombinant von Willebrand factor (Vonvendi - Shire) for adults with von Willebrand disease (VWD) who require on-demand treatment and control of bleeding episodes. It is the first recombinant von Willebrand factor (VWF) product to become available in the US.

The FDA has approved Duzallo (Ironwood), a fixed-dose combination of the uric acid transporter 1 (URAT1) inhibitor lesinurad (Zurampic) and the xanthine oxidase inhibitor allopurinol (Zyloprim, and generics), for once-daily treatment of gout-associated hyperuricemia in patients who have not achieved target serum uric acid levels with allopurinol alone.

Coagulation factor Xa (recombinant), inactivated-zhzo (andexanet alfa; Andexxa – Portola) has received accelerated approval from the FDA for urgent reversal of the anticoagulant effect of the direct factor Xa inhibitors apixaban (Eliquis) and rivaroxaban (Xarelto). Andexanet alfa is the second antidote for a direct oral anticoagulant to become available in the US, and the fi rst for factor Xa inhibitors. Idarucizumab (Praxbind) was approved in 2015 for reversal of the anticoagulant effect of the direct thrombin inhibitor dabigatran etexilate (Pradaxa). Andexanet alfa has not...

View the Expanded Table: Some Drugs for Altitude Illness, Jet Lag, and Motion Sickness

Voclosporin (Lupkynis – Aurinia), an oral calcineurin inhibitor, has been approved by the FDA for use in combination with the antimetabolite immunosuppressant mycophenolate mofetil (Cellcept, and generics) and a corticosteroid for treatment of adults with active lupus nephritis. It is the first calcineurin inhibitor to be approved in the US for this indication. Tacrolimus (Prograf, and others) and cyclosporine (Neoral, and others), the other available systemic calcineurin inhibitors, are approved for prophylaxis of organ rejection in transplant patients.

The FDA has approved the complement factor B inhibitor iptacopan (Fabhalta – Novartis) for treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adults. Iptacopan is the first oral drug to be approved in the US for this indication. Three parenterally administered drugs, the complement C5 inhibitors eculizumab (Soliris) and ravulizumab (Ultomiris) and the complement C3 inhibitor pegcetacoplan (Empaveli), are also approved for treatment of PNH.

Sebetralstat (Ekterly – Kalvista), an oral plasma kallikrein inhibitor, has been approved by the FDA for treatment of acute hereditary angioedema (HAE) attacks in patients ≥12 years old. It is the first oral drug to be approved in the US for this indication. The intravenous C1 esterase inhibitors (C1INHs) Berinert and Ruconest, the subcutaneous plasma kallikrein inhibitor ecallantide (Kalbitor), and the subcutaneous bradykinin B2 receptor antagonist icatibant (Firazyr) have been available for years for on-demand treatment of HAE attacks; all of these drugs except ecallantide can...

The recommendations for treatment of varicella-zoster virus (VZV) and herpes simplex virus (HSV) infections are listed in tables 1 and 2. Vaccination against VZV was reviewed in a previous issue.

Levodopa combined with carbidopa (Sinemet) is the treatment of choice for Parkinson's disease (Medical Letter, 30:113, 1988). After prolonged treatment, however, the symptoms of the disease often become difficult to manage. The benefit from each dose becomes shorter (the 'wearing-off' effect), sudden fluctuations occur between mobility and immobility (the 'on-off' phenomenon), and abnormal involuntary movements (dyskinesias) may become frequent. The dopamine agonist bromocriptine (Parlodel) can ameliorate some of these effects. Two new drugs, pergolide (Permax - Lilly), another dopamine...