Omlyclo (omalizumab-igec; Celltrion), a biosimilar product interchangeable with the recombinant anti-IgE monoclonal antibody Xolair, has been approved by the FDA for same indications as Xolair (see Table 1). Omlyclo is the first Xolair biosimilar to be approved in the US.

The FDA has approved siponimod (Mayzent – Novartis), a sphingosine 1-phosphate (S1P) receptor modulator, for oral treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Siponimod is the second S1P receptor modulator to be approved in the US; fingolimod (Gilenya), which is approved for oral treatment of relapsing forms of MS in patients ≥10 years old, was the first. The purine antimetabolite cladribine (Mavenclad) was also...

The FDA has approved letermovir (Prevymis – Merck), a cytomegalovirus (CMV) DNA terminase complex inhibitor, for prophylaxis of CMV infection and disease in CMV-seropositive adult recipients of an allogeneic hematopoietic cell transplant (HCT). Letermovir is the first CMV DNA terminase complex inhibitor to be approved in the US and the only drug specifically indicated for CMV prophylaxis in HCT patients. It is not approved for treatment of CMV infection.

On June 25, 2021, the FDA added a warning to the Fact Sheets for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) about an increased risk of myocarditis and pericarditis following administration of the vaccines.

Cytomegalovirus immune globulin (CMVIG) for intravenous administration is now available in the USA on an investigational basis (FE Young and SL Nightingale, JAMA, 260:224, July 8, 1988) for prevention of cytomegalovirus (CMV) infection in CMV-seronegative renal transplant recipients who receive a kidney from a seropositive donor. CMVIG contains IgG antibodies from a pool of healthy donors with high titers of antibodies against CMV. The drug can be obtained from the Massachusetts Department of Public Health Biologic Laboratories (617-522-3700, extension 264) or the American Red Cross...

The FDA has approved the marketing of certolizumab pegol (Cimzia - UCB), a tumor necrosis factor (TNF) blocker, for treatment of moderate to severe Crohn's disease refractory to conventional treatment. It is the third TNF blocker approved for this indication.

The FDA has required manufacturers of the oral P2Y₁₂ platelet inhibitors clopidogrel (Plavix, and generics), prasugrel (Effient, and generics), and ticagrelor (Brilinta) to warn in the product labels that the absorption of these drugs may be delayed or reduced when taken with an opioid agonist.

The Medical Letter has received many inquiries about use of glucosamine, a basic constituent of articular cartilage glycosaminoglycans, for treatment of arthritis. A recently published book (The Arthritis Cure), several television news shows, and articles in The New York Times have suggested it may be effective for treatment of osteoarthritis. Glucosamine is sold as a 'dietary supplement' in the USA.

Belotero Balance (Merz), an injectable hyaluronic acid dermal filler, has been approved by the FDA for temporary correction of moderate-to-severe facial wrinkles and folds. Several other hyaluronic acid products are also available for this indication (e.g., Restylane, Perlane, Juvéderm). They have supplanted bovine collagen products, which persist for a shorter time and cause more allergic reactions.

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).