The FDA has approved vorapaxar (Zontivity – Merck), an oral protease-activated receptor-1 (PAR-1) antagonist, for use with aspirin and/or clopidogrel to reduce the risk of thrombotic cardiovascular events in patients with peripheral arterial disease or a history of myocardial infarction (MI). It is the first PAR-1 antagonist to be approved by the FDA.

The FDA has approved efinaconazole 10% solution (Jublia – Valeant) for topical treatment of toenail onychomycosis due to Trichophyton rubrum and/or Trichophyton mentagrophytes. It is the first topical triazole antifungal drug to be approved for this indication. A topical oxaborole antifungal solution, tavaborole 5% (Kerydin – Anacor), also recently approved by the FDA for the same indication will be reviewed in a future issue.

Erdafitinib (Balversa – Janssen), an oral kinase inhibitor, has received full approval from the FDA for treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3 (fibroblast growth factor receptor) genetic alterations who had disease progression on or after at least one prior line of systemic therapy. It is not recommended for use in patients who are eligible for but have not received prior PD-1 (programmed death receptor-1) or PD-L1 (programmed death-ligand 1) inhibitor therapy. Erdafitinib is the first oral FGFR kinase inhibitor to be...

Glaucoma is a progressive optic neuropathy associated with increased intraocular pressure (IOP; normal range 8-22 mm Hg), which is the only disease-related factor that can be modified. Topical drugs that lower IOP are the first line of treatment for open-angle glaucoma.

Paclitaxel (Taxol - Bristol-Myers Squibb) is now available in the USA for treatment of metastatic ovarian cancer refractory to other drugs. The new drug is a natural product extracted in small amounts from the inner bark of the Western yew tree found mainly in the Pacific northwest (Taxus brevifolia). Efforts to synthesize the drug have been unsuccessful to date, but a semi-synthetic product (taxotere) prepared from the needles of European yews has shown some promise (R Pazdur et al, J Natl Cancer Inst, 89:1781, 1992), and a fungus (Taxomyces andreanae) growing on the Pacific yew was...

Rimantadine hydrochloride (Flumadine - Forest), the alpha-methyl derivative of amantadine (Symmetrel, and others), was recently approved by the US Food and Drug Administration for prevention and treatment of influenza A virus infections in adults and for prevention of influenza in children.

Eplerenone (e pler' en one; Inspra - Pharmacia), an aldosterone receptor antagonist similar to spironolactone (Aldactone, and others), has been approved by the FDA, but not yet marketed, for treatment of hypertension. It has also been tried for treatment of heart failure.

Bortezomib (PS341; Velcade Millenium), the first proteasome inhibitor, has received accelerated approval from the FDA for treatment of refractory multiple myeloma. This review includes descriptions of the mechanism of action, pharmacokinetics, adverse effects, and dosage and cost of bortezomib, outlines the results of clinical studies, and concludes with an overall assessment of the drug's effectiveness.

The injectable direct thrombin inhibitor desirudin (Iprivask – Canyon), a recombinant analog of hirudin, the leech anticoagulant protein, was approved by the FDA in 2003 for prevention of venous thromboembolism (VTE) after elective hip arthroplasty, but was only marketed recently in the US. It has been available in Europe as Revasc for about 10 years. Two other hirudin analogs are available in the US: lepirudin (Refludan) for treatment of heparin-induced thrombocytopenia (HIT) and bivalirudin (Angiomax) for use in percutaneous coronary intervention (PCI).

The FDA has approved a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) elvitegravir, the pharmacokinetic enhancer cobicistat, and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate (Stribild – Gilead) for treatment of HIV-1 infection in antiretroviral treament-naïve adults. Elvitegravir is the second INSTI to be approved by the FDA for use in HIV treatment; raltegravir (Isentress) was the first.