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.

The FDA has approved the second-generation antipsychotic drug cariprazine (Vraylar — Abbvie) for adjunctive treatment of major depressive disorder (MDD) in adults. Cariprazine was previously approved for treatment of schizophrenia and bipolar depression, and for acute treatment of manic or mixed episodes associated with bipolar I disorder.

View the Table: Treatments Considered for COVID-19

The results of a clinical trial (PRECISION) comparing the cardiovascular safety of the COX-2 selective NSAID celecoxib (Celebrex, and generics) with that of ibuprofen and naproxen, which are nonselective, have been described in the lay press in terms that may overestimate the safety of celecoxib.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) has been approved by the FDA for treatment of adults with chronic kidney disease (CKD) at risk of progression (not defined in the label). Dapagliflozin is the first SGLT2 inhibitor to be approved in the US for treatment of CKD.

Revakinagene taroretcel-lwey (Encelto – Neurotech), an intravitreal allogeneic cell-based gene therapy, has been approved by the FDA for treatment of idiopathic macular telangiectasia type 2 in adults. It is the first treatment to be approved in the US for this indication.

Drugs for gout are used to reduce the pain and inflammation of acute flares, decrease the frequency of exacerbations, and lower serum urate levels to prevent recurrent flares, development of tophi, and joint damage.

Rasagiline (Azilect - Teva), a monoamine oxidase-type B (MAO-B) inhibitor, was recently approved by the FDA for once-daily oral treatment of Parkinson's disease (PD). It can be taken alone for treatment of early disease or with levodopa/carbidopa (Sinemet, and others) for advanced disease. Selegiline (Eldepryl, and others), the first MAO-B inhibitor marketed in the US, has been available since 1988; a new lower-dose disintegrating tablet (Zelapar) was recently approved.

A biodegradable polymer 'wafer' (Gliadel - Rh ne-Poulenc Rorer) impregnated with the alkylating agent carmustine (BCNU; Bicnu) has been marketed in the USA for local treatment of recurrent glioblastoma multiforme that requires re-operation. The dime-sized polyanhydride wafers are implanted into the surgical cavity left behind after resection. Release of the alkylating agent directly into the area of the tumor bypasses the blood-brain barrier (H Brem and R Langer, Sci Med, 3:1, 1996).

Valrubicin (Valstar), formerly known as AD 32, has been approved by the FDA for intravesical treament of bladder cancer. The approval is limited to patients with carcinoma-in-situ refractory to BCG for whom immediate cystectomy is contraindicated.