PDR Drug Update - August 2026

Preventing COVID-19 After Exposure

Although vaccination and other preventive measures have significantly reduced the global impact of COVID-19, the virus continues to circulate widely, and new infections remain common. Individuals who have had recent contact with an infected person remain at risk for developing symptomatic illness with potential for progression to severe disease.

Several antiviral therapies are available for the treatment of mild-to-moderate COVID-19 in patients who are susceptible to severe infection. These include the oral antivirals Paxlovid (nirmatrelvir; ritonavir) and Lagevrio (molnupiravir), as well as the intravenous antiviral Veklury (remdesivir). These therapies have different mechanisms of action, with Paxlovid inhibiting the SARS-CoV-2 main protease, Lagevrio introducing errors during viral RNA replication, and Veklury inhibiting the viral RNA-dependent RNA polymerase. All three of these antivirals are indicated for treatment after infection and are intended to reduce the risk of hospitalization and other severe outcomes. Although effective in appropriate patients, their use is limited to individuals with confirmed COVID-19 infection, and they are not indicated for prevention following exposure. As a result, patients with known exposure have historically relied primarily on monitoring for symptoms and testing after exposure rather than receiving an antiviral intended to prevent infection.

Xocova (ensitrelvir) is a novel oral antiviral recently approved by the FDA for post-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older following contact with an individual with COVID-19. Xocova is a SARS-CoV-2 main protease inhibitor that blocks viral replication by preventing the cleavage of viral polyproteins required for the formation of functional viral proteins. The main protease is essential for the viral life cycle and represents an important target for antiviral development. The recommended dosage of Xocova is 375mg orally on day 1, followed by 125mg orally on days 2 through 5. Treatment should be initiated as soon as possible following COVID-19 exposure.

FDA approval was based on results from a randomized, double-blind, placebo-controlled clinical study evaluating the efficacy of Xocova for post-exposure prophylaxis in household contacts of individuals with COVID-19. The study included more than 2000 household contacts of individuals with COVID-19 who received either Xocova or placebo following a known exposure. Symptomatic COVID-19 occurred in 2.9% of participants receiving Xocova compared with 9.0% of participants receiving placebo.

The safety profile of Xocova was evaluated in clinical studies of patients receiving treatment for COVID-19 and participants receiving post-exposure prophylaxis. Common side effects reported with Xocova include headache, diarrhea, and cough. Xocova is associated with clinically significant drug interactions due to effects on several drug transporters and metabolic pathways. Concomitant use with certain medications is contraindicated or not recommended. Hypersensitivity reactions, including anaphylaxis and angioedema, have also been reported. Xocova may cause fetal harm, and pregnancy status should be considered before initiating treatment.

As the first oral antiviral approved for post-exposure prophylaxis of COVID-19, Xocova provides a new option for eligible patients following a known exposure. Stay informed about emergent drug information, including treatment options for COVID-19, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Lipfendra

The FDA has approved Lipfendra (enlicitide) tablets as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. Learn more about Lipfendra

Lumvoa

The FDA has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration. Learn more about Lumvoa

Revtorpyk

The FDA has approved Revtorpyk (gedatolisib) for the treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Learn more about Revtorpyk

Tregzi

The FDA has approved Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq), clinically known as Orca-T, a precision-engineered cell therapy for use in matched-donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease free survival, in the treatment of adults with hematological malignancies. Learn more about Tregzi

Trutakna

The FDA has approved Trutakna (atacicept-vymj) to reduce proteinuria in adults with primary IgAN at risk for disease progression. Learn more about Trutakna

Xofluza - New Generic

The FDA has approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older. Learn more about generic Xofluza

FDA New Indications

Casgevy

The FDA has approved expanded use of Casgevy (exagamglogene autotemcel) for the treatment of people aged 2 years and older with either sickle cell disease with recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia. Learn more about Casgevy

Fabhalta

The FDA has granted traditional approval of Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy at risk of disease progression. Learn more about Fabhalta

Ibrance

The FDA has approved Ibrance (palbociclib) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-positive locally advanced or metastatic breast cancer following induction treatment. Learn more about Ibrance

Retevmo

The FDA has granted traditional approval of Retevmo (selpercatinib) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Learn more about Retevmo

Skyrizi

The FDA has approved Skyrizi (risankizumab-rzaa) for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. A new 55mg pre-filled syringe (PFS) has also been approved to support weight-based dosing for patients weighing less than 40kg, while the currently available 150mg PFS and Pen are approved for patients weighing 40kg or greater. Learn more about Skyrizi

Tecelra

The FDA has granted full approval of Tecelra (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. Learn more about Tecelra

Trodelvy

The FDA has approved Trodelvy (sacituzumab govitecan-hziy) for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer. Learn more about Trodelvy

Tryngolza

The FDA has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides (TG) and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500mg/dL). Learn more about Tryngolza

Wilate

The FDA has approved Wilate (von Willebrand Factor/Coagulation Factor VIII Complex [Human]) for routine prophylaxis to reduce the frequency of bleeding episodes in pediatric patients with von Willebrand Disease who are younger than 6 years of age. Learn more about Wilate

Xeomin

The FDA has approved expansion of the pediatric upper limb spasticity indication for Xeomin (incobotulinumtoxinA) to include children and adolescents aged 2 years and older living with spasticity associated with cerebral palsy. Learn more about Xeomin

Zegalogue

The FDA has approved an expanded indication for Zegalogue (dasiglucagon) to include pediatric and adult patients with diabetes who weigh at least 20kg (previously approved for patients down to age 6 years). Learn more about Zegalogue

Zoryve

The FDA has approved expansion of the indication for Zoryve (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2. Learn more about Zoryve

FDA New Combinations

Keytruda, Keytruda Qlex with Padcev

The FDA has approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for adult patients with muscle-invasive bladder cancer. Learn more about Keytruda, Keytruda Qlex with Padcev

Keytruda, Keytruda Qlex with Trodelvy

The FDA has approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Trodelvy (sacituzumab govitecan-hziy), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (combined positive score ≥10) as determined by an FDA-authorized test. Learn more about Keytruda, Keytruda Qlex with Trodelvy

FDA New Dosing

Besremi Pen

The FDA has approved the Besremi Pen (ropeginterferon alfa-2b-njft) device for adult patients with polycythemia vera. Learn more about Besremi Pen

Leqembi Iqlik

The FDA has approved once‑weekly subcutaneous Leqembi Iqlik (lecanemab‑irmb) as an initiation dose for the treatment of early Alzheimer’s disease. Learn more about Leqembi Iqlik

Sarclisa Escena

The FDA has approved subcutaneous Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma across all existing indications of Sarclisa intravenous formulation. Learn more about Sarclisa Escena

August 2026