The FDA has approved the oral direct thrombin inhibitor dabigatran (da big’ a tran) etexilate (Pradaxa – Boehringer Ingelheim) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation. It has been available in Canada (Pradax) since 2008 for prevention of thromboembolism in patients undergoing knee or hip replacement surgery and was recently approved there for use in atrial fibrillation.

Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a mitogen-activated kinase (MEK) inhibitor. It is the first cellular therapy to be approved for use in solid tumors. Accelerated approval of lifileucel was based on objective response rates.

Anistreplase (Eminase - SmithKline Beecham, Upjohn), a plasminogen activator also known as APSAC, was recently approved by the US Food and Drug Administration (FDA) for intravenous (IV) thrombolytic treatment of coronary thrombosis. Three other thrombolytic agents - intracoronary urokinase (Abbokinase) and intracoronary or intravenous streptokinase (Streptase; Kabikinase) and alteplase (TPA; Activase)- were previously approved for coronary thrombolysis (Medical Letter, 29:107, 1987).

Disodium pamidronate (Aredia - Ciba-Geigy), an aminohydroxypropilidene bisphosphonate, has been approved by the US Food and Drug Administration for intravenous (IV) treatment of hypercalcemia associated with malignancy, with or without bone metastases. The drug is also being investigated for use in Paget's disease of bone, hyperparathyroidism, and postmenopausal osteoporosis. An oral formulation of pamidronate has been used in Europe, but is not available in the USA.

The ViewPoint CK System (Refractec) for conductive keratoplasty (CK), previously approved by the FDA as a device for treatment of hyperopia (farsightedness), was recently approved for treatment of presbyopia (age-associated loss of ability to view near objects).

The main purpose of vasopressors is to raise arterial blood pressure, while that of inotropes is to increase cardiac contractility. The choice of drugs is dictated by the clinical setting. Controlled trials comparing the efficacy and safety of these drugs are generally lacking.

The FDA has approved Eloctate (Biogen), a recombinant factor VIII Fc fusion protein with an extended half-life, for use in adults and children with hemophilia A. Eloctate is indicated for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. It is the first antihemophilic factor VIII Fc fusion protein to be approved for hemophilia A.

The FDA has approved a new 2.5-mg formulation of the direct factor Xa inhibitor rivaroxaban (Xarelto – Janssen) for use in combination with low-dose aspirin to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). Rivaroxaban is the first direct oral anticoagulant to be approved for this indication. It was approved earlier for prevention and treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for prevention of stroke and systemic embolism in patients with nonvalvular atrial...

The FDA has approved Altuviiio (Sanofi), a von Willebrand Factor (VWF)-independent, recombinant factor VIII concentrate, for routine prophylaxis, on-demand treatment to control bleeding episodes, and perioperative management of bleeding in children and adults with hemophilia A. The manufacturer claims that Altuviiio, which was previously called efanesoctocog alfa, delivers normal to near-normal factor VIII levels for most of the week with once-weekly intravenous dosing.

Concizumab (Alhemo – Novo Nordisk), a subcutaneously injected tissue factor pathway inhibitor (TFPI) antagonist, has been approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years old who have hemophilia A with factor VIII inhibitors or hemophilia B with factor IX inhibitors. It is the second TFPI antagonist to be approved in the US for treatment of hemophilia A or B; the TFPI antagonist marstacimab (Hympavzi) is approved for use in patients without inhibitors.