PDR Drug Update - August 2025

Accelerated Progress Toward Eliminating HIV Transmission

More than forty years after it began, the HIV epidemic persists, with 1.3 million new infections occurring worldwide each year. Overall, more than 40 million people are infected, globally. Advances in treatment and prevention have made significant progress, but a cure or immunization is still not available. However, progression in research leading to a new approval with nearly 100% efficacy for HIV prevention is transforming the potential to truly interrupt and perhaps someday stop transmission of the virus.

A watershed moment occurred with the recent FDA approval of Yeztugo (lenacapavir) injection, for subcutaneous use. The active ingredient, lenacapavir, effectively blocks HIV replication as a capsid inhibitor. These inhibitors are part of a new antiretroviral medication class marked by a highly unique and complex mechanism of action that includes inhibition of capsid nuclear import, uncoating, and assembly. Lenacapavir is a long-acting, pre-exposure prophylaxis (PrEP) that was first approved for treating multidrug-resistant HIV in 2022. Now the medication can be administered as a twice-yearly injectable for the prevention of HIV in adults and adolescents weighing at least 77 pounds. Its simplified dosing schedule can make lenacapavir a valuable alternative for those who cannot manage taking daily oral PrEP or find the more-frequent dosing of other medication types to be a barrier to adherence.

Lenacapavir has the potential to be a transformative option for PrEP. All PrEP is extremely useful for preventing HIV infection from occurring and spreading. Today, there are two daily oral PrEP medications and two long-acting injectable forms of PrEP. The differentiator for lenacapavir is that, instead of requiring an injection every other month, its dosing only needs to occur twice a year. Its unique dosage and administration begin with an HIV screening, with a necessary test for HIV-1 infection prior to initiation, each subsequent injection, and as clinically appropriate. The initiation dosing includes two 1.5mL subcutaneous injections and two 300mg tablets on Day 1. The Day 2 step is another 600mg orally. Following the start-up dosing, two 1.5mL subcutaneous injections will be given every six months.

Just a few weeks after the approval for twice-yearly lenacapavir, the World Health Organization (WHO) released updated guidelines that recommend the use of injectable lenacapavir twice a year as an additional PrEP option for HIV prevention. An increased use of PrEP may result from having new choices available that better meet patient needs and preferences. An additional library of published clinical guidelines related to HIV prevention through PrEP is available on HIVinfo.NIH.gov, which is provided in collaboration with the National Institutes of Health’s Office of AIDS Research.

The organizations devoted to spreading awareness and providing solutions to combat the HIV epidemic all incorporate the issues of affordability and accessibility into their approaches to determining recommendations. In the US, insurance coverage and funding for HIV prevention efforts are in flux. Stateside, the Ending the HIV Epidemic in the US (EHE) initiative is in place to help address barriers, with an aim to “substantially reduce HIV infections…by scaling up four science-based strategies: diagnose, treat, prevent, and respond.” Part of the EHE online tools is a convenient HIV Services Locator, which individuals can use to find a suitable PrEP provider and other HIV resources.

In order to help prevent HIV, it is important for patients to have knowledge of these resources and for healthcare providers to actively prescribe PrEP to patients who are at an increased risk. Prescribers do not need to have a specialization in infectious disease or HIV in order to prescribe PrEP. Any licensed prescriber can prescribe PrEP for patients. To support prescribers who would like advisement regarding managing patients on PrEP, the National Clinician Consultation Center has an established hotline, 844-ASK-NCCC or 844-275-6222, which is available Monday through Friday, 8 am to 4 pm PT, excluding holidays.

Expanding knowledge and resources regarding PrEP are helping make treatment more widely available and bringing the healthcare community closer to ending the ongoing HIV epidemic. Stay informed about emergent drug information, including medications for PrEP, 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

Anzupgo

The FDA has approved Anzupgo (delgocitinib) cream (20mg/g) for the topical treatment of moderate-to-severe chronic hand eczema in adults who have had an inadequate response to or for whom topical corticosteroids are not advisable. Learn more about Anzupgo

Ekterly

The FDA has approved Ekterly (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema in adult and pediatric patients aged 12 years and older. Learn more about Ekterly

Gamifant

The FDA has approved Gamifant (emapalumab-lzsg) for the treatment of adult and pediatric (newborn and older) patients with hemophagocytic lymphohistiocytosis/macrophage activation syndrome (MAS) in known or suspected Still's disease, including systemic juvenile idiopathic arthritis, with an inadequate response or intolerance to glucocorticoids, or with recurrent MAS. Learn more about Gamifant

Gammagard Liquid ERC

The FDA has approved Gammagard Liquid ERC [immune globulin infusion (human)] with less than or equal to 2µg/mL IgA in a 10% solution, the only ready-to-use liquid immunoglobulin therapy with low immunoglobulin A content, as replacement therapy for people aged two and older with primary immunodeficiency. Learn more about Gammagard Liquid ERC

Kirsty

The FDA has approved Kirsty (insulin aspart-xjhz), 100 units/mL as the first and only interchangeable biosimilar to NovoLog (insulin aspart). Kirsty is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. Learn more about Kirsty

Lynozyfic

The FDA has granted accelerated approval for Lynozyfic (linvoseltamab-gcpt) to treat adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Learn more about Lynozyfic

Zegfrovy

The FDA has approved Zegfrovy (sunvozertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Learn more about Zegfrovy

FDA New Indications

Doptelet

The FDA has approved Doptelet (avatrombopag) for the treatment of thrombocytopenia in pediatric patients aged one year and older with persistent or chronic immune thrombocytopenia who have had an insufficient response to a prior therapy. Learn more about Doptelet

Kerendia

The FDA has approved Kerendia (finerenone) to treat patients with heart failure with left ventricular ejection fraction ≥40%. Learn more about Kerendia

Spikevax

The FDA has approved the sBLA for Spikevax COVID-19 vaccine, in children aged 6 months through 11 years who are at increased risk for COVID-19 disease. Learn more about Spikevax

FDA Labeling Changes

Amyvid

The FDA has approved a label update to support diagnosis of Alzheimer's disease in patients for Amyvid (florbetapir F 18 injection) for intravenous use. Amyvid is used for brain imaging to estimate amyloid plaque density in patients with cognitive impairment being evaluated for Alzheimer's disease and other causes of cognitive decline. Learn more about Amyvid

FDA New Dosing

Kisunla

The FDA has approved a label update with a new recommended titration dosing schedule for Kisunla (donanemab-azbt), the once-monthly amyloid-targeting therapy for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment as well as people in the mild dementia stage of AD, with confirmed amyloid pathology. Learn more about Kisunla

Shingrix

The FDA has approved a prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles (herpes zoster). The new prefilled syringe removes the need to reconstitute separate vials prior to administration, simplifying the vaccine administration process for healthcare professionals. Learn more about Shingrix

FDA Recalls

Nostrum Laboratories Sucralfate Tablets

Nostrum Laboratories is initiating a voluntary recall of sucralfate tablets USP 1g, all lots within expiry, as a result of closures and discontinuation of its quality activities after ceasing and shutting operations and terminating its operational employees at all domestic US sites. Learn more about the Nostrum Laboratories sucralfate tablets recall

Sandoz Cefazolin for Injection

Sandoz is initiating a voluntary recall of one lot of cefazolin for injection, USP, 1g/vial. This single lot is being recalled due to a customer complaint indicating that four penicillin G potassium for injection, USP, 20 million units labelled vials were incorrectly included in a carton (25 vials per carton) of cefazolin for injection, USP 1g/vial product. Learn more about the Sandoz cefazolin for injection recall

FDA Alerts

Extended-Release Stimulants for ADHD

The FDA is revising the labeling of all extended-release stimulants indicated to treat attention-deficit/hyperactivity disorder (ADHD), including certain formulations of amphetamine and methylphenidate, to warn about the risk of weight loss and other adverse reactions in patients younger than 6 years taking these medications. Learn more about the extended-release stimulants drug safety communication

August 2025