The investigational anti-complement component 5a (C5a) antibody vilobelimab (Gohibic – InflaRx) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of hospitalized adults with COVID-19 beginning within 48 hours after invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) is started. Vilobelimab is the first anti-C5a antibody to become available in the US.

Tisotumab vedotin-tftv (Tivdak – Seagen/Genmab), a tissue factor-directed antibody and microtubule inhibitor conjugate, has received full approval from the FDA for treatment of recurrent or metastatic cervical cancer that progressed on or after chemotherapy. It is the first antibody-drug conjugate to be approved for treatment of cervical cancer. The drug received accelerated approval from the FDA in 2021 for the same indication.

The FDA has approved nivolumab (Opdivo – BMS), an IV programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (and a BRAF inhibitor in patients who are BRAF V600 mutation positive) and for treatment of metastatic squamous non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy. It is the second PD-1 inhibitor to be marketed in the US after pembrolizumab (Keytruda), and the first to be approved for treatment of NSCLC.

The FDA has approved delafloxacin (Baxdela – Melinta), an anionic fluoroquinolone antibiotic, for oral and parenteral treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is the first fluoroquinolone to be approved for treatment of MRSA.

View the Comparison Table: Some Drugs for Gout

Monoclate (Armour), a formulation of Factor VIII (antihemophilic factor; AHF) prepared by immunoaffinity chromatography, was recently approved for marketing by the US Food and Drug Administration. The new product is claimed to be more highly purified than older AHF formulations. Factor VIII concentrates commercially available in the USA are listed in the table below.

Cerebral arterial spasm frequently causes ischemic neurological damage after subarachnoid hemorrhage from a ruptured intracranial aneurysm. Nimodipine (Nimotop - Miles), a 1,4-dihydropyridine calcium-entry blocker, was recently approved by the US Food and Drug Administration (FDA) for oral treatment of such patients; an intravenous preparation is available only for investigational use.

Ondansetron (on dan' se tron; Zofran - Glaxo), a serotonin (5-hydroxytryptamine) antagonist, was recently marketed in the USA for intravenous use to prevent nausea and vomiting due to cancer chemotherapy. An oral formulation is available in many other countries.

Tacrolimus (Prograf - Fujisawa), previously called FK506 (Medical Letter, 33:94, 1991), has been approved by the US Food and Drug Administration for primary prevention of organ rejection in patients receiving liver transplants. The drug has also been used as rescue therapy for organ graft rejection unresponsive to cyclosporine (Sandimmune) and other immunosuppressive drugs.

Lispro insulin (Humalog - Lilly), a synthetic insulin analog, has been approved for marketing by the US Food and Drug Administration. Prepared by recombinant DNA methods using E. coli, lispro differs from human insulin in having lysine and proline at positions 28 and 29 on the beta-chain, reversed from their natural position. The new drug has biologic effects similar to unmodified insulin, but is absorbed more rapidly after subcutaneous injection.