The FDA has approved (Giapreza) (La Jolla), an IV formulation of synthetic angiotensin II, to increase blood pressure in adults with septic or other vasodilatory shock, such as anaphylactic or neurogenic shock. Angiotensin is a naturally occurring peptide hormone in the renin-angiotensin-aldosterone system (RAAS). (Giapreza) is the first synthetic angiotensin II product to become available in the US.

The FDA has approved Vivlodex (Iroko), a low-dose formulation of the nonsteroidal anti-inflammatory drug meloxicam (Mobic, and generics), for management of osteoarthritis pain. According to the manufacturer, the new formulation aligns with stronger FDA warnings about the cardiovascular risks of NSAIDs and the recommendation to use the lowest possible doses of these drugs.

Anagrelide (an ag' gre lide) hydrochloride (Agrylin - Roberts), a quinazolin derivative, has been approved by the FDA for oral treatment of essential thrombocythemia. Patients with this uncommon myeloproliferative disorder have an increased number of circulating platelets and are at risk for both thrombosis and hemorrhage.

Agalsidase beta (Fabrazyme Genzyme) has received accelerated approval from the FDA for treatment of patients with Fabry disease, an inherited lysosomal storage disease caused by deficiency of α-galactosidase A. Agalsidase beta is a recombinant form of human α-galactosidase A. This review provides an overview of this rare disease, including its clinical manifestations. The clinical trials conducted with the new drug are also described, as well as its adverse effects, dosage, and cost. Appropriate indications for use of Fabrazyme are summarized.

The FDA has approved tafamidis, an oral transthyretin stabilizer, in 2 different formulations (see Table 1) for treatment of adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). Tafamidis is the first drug to be approved in the US for this indication. Patisiran (Onpattro), a transthyretin-directed small interfering RNA, and inotersen (Tegsedi), a transthyretin-directed antisense oligonucleotide, were both recently approved for hereditary transthyretin amyloid polyneuropathy.THE DISEASE — ATTR-CM is a progressive life-threatening disease caused by destabilization of the...

The FDA has approved the erythropoiesis-stimulating agent (ESA) peginesatide (Omontys – Affymax/Takeda), a synthetic peptide analog of erythropoietin, for treatment of anemia in patients with chronic kidney disease (CKD) who are on dialysis. Peginesatide is the third ESA to become available in the US.Overuse of the other two, which have broader indications, has been a concern.

The FDA has approved the neoadjuvant (preoperative) use of pertuzumab (Perjeta – Genentech) in combination with trastuzumab (Herceptin) and docetaxel (Taxotere, and generics) for treatment of locally advanced, inflammatory, or early-stage HER2 (human epidermal growth factor receptor 2)-positive breast cancer patients with tumors >2 cm in diameter or node-positive disease. Pertuzumab in combination with trastuzumab and docetaxel was approved earlier for treatment of HER2-positive metastatic breast cancer. Pertuzumab is the first drug to be approved for neoadjuvant treatment of...

Hypertensive emergencies include hypertensive encephalopathy, intracranial hemorrhage with hypertension, aortic dissection, acute pulmonary edema with hypertension, acute cardiac ischemia with hypertension, malignant hypertension and severe hypertension after vascular surgery; hypertensive crisis due to pheochromocytoma or occurring during pregnancy is not discussed in this review. Although immediate reduction of blood pressure is necessary in hypertensive emergencies, an excessive decrease may cause stroke, myocardial infarction or visual changes. Most experienced clinicians aim...

Golimumab (Simponi - Centocor), a fully humanized anti-tumor necrosis factor (TNF)-a antibody, has been approved by the FDA for the treatment of: (1) moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate; (2) active psoriatic arthritis (PsA) alone or in combination with methotrexate; and (3) active ankylosing spondylitis (AS).

View Expanded Table: Some Biologic Drugs and JAK Inhibitors for Rheumatoid Arthritis