Eculizumab (Soliris - Alexion) has been approved by the FDA for reduction of hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare form of hemolytic anemia. A recombinant humanized monoclonal antibody, eculizumab is the first drug to be marketed for this indication.

The FDA has approved tofacitinib (toe” fa sye’ ti nib; Xeljanz – Pfizer), an oral Janus kinase (JAK) inhibitor, for treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to or are intolerant of methotrexate. Ruxolitinib (Jakafi) is the only other JAK inhibitor available in the US; it is FDA-approved for treatment of myelofibrosis.

Mupirocin (Bactroban - Beecham), a topical antibiotic formerly called pseudomonic acid, was recently approved by the US Food and Drug Administration for treatment of impetigo. It will be sold as a 2% ointment available only by prescription.

The FDA has approved the immune checkpoint inhibitor pembrolizumab (Keytruda – Merck), a programmed death receptor-1 (PD-1) inhibitor, for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) that highly expresses programmed death-ligand 1 (PD-L1) and has no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocations. About 25% of patients with advanced NSCLC have tumors with high levels of PD-L1 expression (PD-L1 expressed on ≥50% of tumor cells). Pembrolizumab was approved earlier for treatment...

The FDA has approved the interleukin (IL)-23 blocker guselkumab (Tremfya – Janssen) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Guselkumab is the first selective IL-23 blocker to become available in the US.

Human alpha1-proteinase inhibitor (Prolastin Cutter), possibly better known as alpha1-antitypsin (ATT), is now available in the USA for replacement therapy in patients with emphysema who have a congential deficiency of the protein.

Pegademase (Adagen - Enzon), bovine adenosine deaminase (ADA) conjugated with polyethylene glycol (PEG), was recently approved by the US Food and Drug Administration as an 'orphan drug' for treatment of severe combined immunodeficiency disease (SCID). SCID due to inherited deficiency of ADA occurs in less than one per million births; until recently, without extraordinary isolation measures, it was usually fatal before the age of two.

Prosorba, an antibody-adsorbing column used with plasmapheresis, has been approved by the FDA for treatment of moderate-to-severe rheumatoid arthritis in patients refractory or intolerant to methotrexate and other disease-modifying anti-rheumatic drugs (DMARDs).

Recent reports (D Kaye.Clin Infect Dis April 1, 2008;46:iii) indicate that 2 of the 3 components of this year's influenza vaccine (Med Lett Drugs Ther 2007;49:81), the influenza B and A/H3N2 antigens, do not matchup well with circulating strains. The B component is probably not protective. The A/H3N2 antigen in the vaccine probably provides some protection, particularly for high-risk patients. The third component, the A/H1N1 antigen, is protective against circulating A/H1N1 influenza viruses, but these viruses, unlike previous A/H1N1 strains, are developing some resistance to oseltamivir...

Chelation therapy involves oral administration, intravenous infusion or intramuscular injection of drugs that increase excretion of heavy metals. The Medical Letter’s last article on this subject found no evidence that it was effective for treatment of cardiovascular disease. Since then, off-label use of chelation therapy has expanded to include treating children with autism and adults with Alzheimer’s disease, cancer and other chronic diseases.

Click here to view the free full article.