Pegloticase (Krystexxa – Savient), a PEGylated urate oxidase enzyme, has been approved by the FDA for intravenous (IV) treatment of chronic symptomatic gout in adults who have not responded to maximum doses of a xanthine oxidase inhibitor, such as allopurinol (Zyloprim, and others). Pegloticase is the second new drug approved for gout in more than 40 years; a new xanthine oxidase inhibitor, febuxostat (Uloric), was approved in 2009.

The FDA has approved an inhaled fixed-dose combination of the long-acting anticholinergic umeclidinium (ue mek" li din' ee um) and the long-acting beta₂-adrenergic agonist (LABA) vilanterol (Anoro Ellipta – GSK/Theravance) for once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). Anoro Ellipta is the first product available in the US that combines two long-acting bronchodilators in a single delivery device.

The FDA has approved 3 allergen extracts for sublingual administration as immunotherapy for allergic rhinitis confirmed by a positive skin test or in vitro testing for pollen-specific IgE antibodies: Oralair (Stallergenes S.A./Greer) and Grastek (Merck) for grass pollen-induced allergic rhinitis and Ragwitek (Merck) for short ragweed pollen-induced allergic rhinitis.

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.

The FDA has approved Verkazia (Santen), a 0.1% ophthalmic emulsion formulation of the calcineurin inhibitor cyclosporine, for treatment of vernal keratoconjunctivitis (VKC). Verkazia is the first product to be approved in the US for this indication.

The FDA has approved ixekizumab (Taltz – Lilly), an injectable humanized interleukin (IL)-17A antagonist, for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Ixekizumab is the second IL-17A antagonist to be approved for this indication in the US; secukinumab (Cosentyx – Novartis) was the first.

Granisetron, a serotonin (5-HT) antagonist similar to ondansetron, was recently approved by the US Food and Drug Administration for prevention of nausea and vomiting due to cancer chemotherapy. Although available in an oral formulation in other countries, granisetron is available here only for intravenous (IV) use.

Bexarotene, a retinoid analog, has been approved by the US Food and Drug Administration for oral treatment of dermatologic manifestations of refractory cutaneous T-cell lymphoma.

Formoterol fumarate inhalation powder Foradil Aerolizer, a long-acting beta2-adrenergic receptor agonist, has been approved by the FDA for maintenance treatment of asthma and prevention of exercise-induced bronchospasm. The drug has been available in Europe for many years.

Balsalazide disodium (Colazal), a prodrug of mesalamine, was marketed in the US this year for oral treatment of mildly to moderately active ulcerative colitis. Oral formulations of mesalamine have been available in the US for nine years for treatment and maintenance of remissions and olsalazine, which is a dimer of mesalamine, is marketed for maintenance of remissions but not for treatment. Balsalazide has been available in Europe for four years.