The FDA has approved the use of recombinant human antithrombin (rhAT; ATryn - Lundbeck) in patients with inherited antithrombin (AT) deficiency to prevent thrombosis during or after surgery or childbirth. The protein is produced in the milk of transgenic goats carrying a copy of the human cDNA for AT. This is the first US drug approval for a protein produced by a transgenic animal. ATryn has been used in Europe since 2006.

Sarecycline (Seysara — Allergan), a new oral tetracycline antibiotic, has been approved by the FDA for once-daily treatment of inflammatory lesions of non-nodular moderate to severe acne in patients ≥9 years old.

The FDA has approved sacituzumab govitecan-hziy (Trodelvy – Immunomedics), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease. It is the first Trop-2-directed antibody-drug conjugate to become available in the US.

The FDA has approved Cabtreo (Bausch Health), a gel containing the retinoid adapalene, the oxidizing agent benzoyl peroxide, and the antibiotic clindamycin, for treatment of acne vulgaris in patients ≥12 years old. Cabtreo is the first three-drug topical formulation to become available in the US for treatment of acne.

Rheumatoid arthritis (RA) is prevalent in 0.5% of adults in the US; it is about 2.5 times more common in women than in men. Guidelines for treatment of RA from the American College of Rheumatology were recently updated. The goal of treatment is to minimize disease activity and prevent irreversible joint damage.

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.

Ketoconazole (Nizoral - Janssen), an imidazole antifungal drug widely used in a tablet formulation for treatment of systemic fungal infections (Medical Letter 36:16, 1994) and as a topical preparation for fungal skin infections, is also available as a shampoo for treatment of seborrheic dandruff. The shampoo is sold only by prescription.

Saw palmetto, an "herbal supplement,"is now being heavily promoted to the general public for treatment of urinary symptoms related to prostatic enlargement. It has not been approved for any use by the FDA.

Breaking drug tablets in half is a common practice. Since our last article on this subject, some new data have become available.

The tissue plasminogen activator (tPA) tenecteplase (TNKase – Genentech) has been approved by the FDA for treatment of acute ischemic stroke in adults. It is the second tPA to be approved in the US for this indication; alteplase (Activase) was approved in 1996. Tenecteplase was approved in 2000 to reduce the risk of death associated with acute ST-elevation myocardial infarction (STEMI).